Clinical Trials Report: Teleprevir
 
  Trial Title Common Trial ID Database Drugs Sponsor(s) Brief Summary Overall Status Enrollment
1. An Open-label, Single-arm, Roll-over Trial of Telaprevir in Combination With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) for Subjects From the Control Group of the VX- 950-TiDP24-C216 Trial Who Failed Therapy for Virologic Reasons. NCT01054573
1.1CT.gov | link
1.2TrialTrove | link
1.3Adis CTI | link
telaprevir
peginterferon alfa-2a (SC)
ribavirin, Roche
Tibotec BVBA
Vertex Pharmaceuticals Incorporated
This trial will assess the efficacy of telaprevir [Vertex Pharmaceuticals] + peginterferon alfa 2a [Pegasys] + ribavirin [Copegus] in patients with hepatitis C. The primary endpoint is efficacy. This will be assessed at 24 weeks. Closed 120 (12 subjects in France, 4 subjects in Italy, 50 subjects in Europe)
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2. A Randomized, Parallel-Group, Dose-Ranging Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Antiviral Activity of VX-222 and Telaprevir in Combination With and Without Peginterferon-Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C. NCT01080222
2.1CT.gov | link
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2.3Adis CTI | link
telaprevir
VX-222
peginterferon alfa-2a (SC)
ribavirin, Roche
Vertex Pharmaceuticals Incorporated The purpose of this study is to assess the safety and efficacy of combination treatment with VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and/or ribavirin. The subjects enrolled in this study are chronically infected with hepatitis C virus (HCV) genotype 1 and will not have previously received treatment for their HCV infection. [CONT.] Open 150
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3. A Randomized, Open-label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-naive Subjects With Genotype 1 Chronic Hepatitis C Virus Infection. NCT01241760
3.1CT.gov | link
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3.3Adis CTI | link
Peginterferon-alfa-2a
Ribavirin
Telaprevir
Tibotec BVBA
Vertex Pharmaceuticals Incorporated
To evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naive patients with chronic HCV genotype 1 infection. To evaluate the effectiveness of telaprevir administered orally as 1125 milligram (mg) twice daily versus 750mg every 8 hours in combination with Peg-IFN-alfa-2a, administered via intramuscular [CONT.] Active, not recruiting 704 [EEA- 352 patients, 40 subjects in Italy]
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4. A Phase 1, Open-label, Randomized, Crossover Study in 20 Healthy Subjects to Investigate the Potential Pharmacokinetic Interaction Between Telaprevir and Raltegravir, Both at Steady-state NCT01253551
4.1CT.gov | link
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raltegravir (tablet)
telaprevir
Tibotec BVBA
Vertex Pharmaceuticals Incorporated
This study will investigate clinically relevant interactions between telaprevir and raltegravir at steady-state in volunteers. The primary endpoint will be blood levels of telaprevir and raltegravir when given alone versus when given together. This will be assessed at day 7 of telaprevir treatment and days 4 and 11 of raltegravir + telaprevir treatment. Completed 20
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5. A Phase 1, Open-Label, Single-Sequence Study to Examine the Effect of Telaprevir on the Pharmacokinetics of Buprenorphine in Subjects on Stable Buprenorphine/Naloxone Maintenance Therapy. NCT01275599
5.1CT.gov | link
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5.3Adis CTI | link
buprenorphine + naloxone
telaprevir
Vertex Pharmaceuticals Incorporated
Tibotec BVBA
The purpose of this study is to investigate the drug-drug interaction potential between telaprevir and buprenorphine/naloxone. An understanding of the interaction potential will help to determine whether buprenorphine dose adjustments are necessary for patients who are concomitantly treated with telaprevir.
Telaprevir, in combination with other antiviral agents, is being investigated for the treatment of chronic hepatitis C virus infection [CONT.]
Completed 16
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6. Pilot Study of PegInterferon-Ribavirin-Telaprevir Efficacy and Tolerability in HIV-HCV Coinfected Patients Who Had Previously Failed a PegInterferon-Ribavirin Regimen. (ANRS HC26 TelapreVIH) NCT01332955
6.1CT.gov | link
6.2TrialTrove | link
6.3Adis CTI | link
telaprevir
atazanavir sulfate (capsule)
efavirenz
Emtricitabine
lamivudine
peginterferon alfa-2a (SC)
raltegravir (tablet)
ribavirin (oral)
ribavirin, Roche
ritonavir, soft gel
tenofovir
French National Agency for Research on AIDS and Viral Hepatitis
Janssen-Cilag Ltd.
To evaluate the efficacy of combination therapy peginterferon-Ribavirin-telaprevir in patients co-infected HIV-HCV, in a failed previous treatment with peginterferon and ribavirin. To estimate the sustained virological response rate (SVR) following a 12 weeks treatment by telaprevir combined with a 48 or 72 weeks treatment by peginterferon and ribavirin, based upon the rapid virological response (RVR) at week 8 (4 weeks after telaprevir start) [CONT.] Open 80 (68 in France)
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7. A Phase I, Open Label, Randomized, 2-Panel, 2-Way Crossover Trial to Investigate the Pharmacokinetic Interaction Between Etravirine or TMC278 and Telaprevir at Steady-State in Healthy Subjects. NCT01336829
7.1CT.gov | link
7.2TrialTrove | link
7.3Adis CTI | link
etravirine (tablet)
rilpivirine
telaprevir
Tibotec Pharmaceuticals, Ireland This study will investigate the pharmacokinetic interaction between etravirine or rilpivirine [TMC-278] and telaprevir at steady-state in volunteers. The primary endpoints are blood levels of telaprevir, etravirine, and rilpivirine following co-administration. Closed 32
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8. A Randomized Trial of Telaprevir, Peginterferon, and Ribavirin Versus Peginterferon and Ribavirin for Treatment of Genotype 1 Hepatitis C Virus With Host Interleukin 28B CC Polymorphism. NCT01415141
8.1CT.gov | link
8.2TrialTrove | link
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peginterferon alfa-2a (SC)
ribavirin (oral)
telaprevir
University of Vermont Chronic hepatitis C is a major cause of liver disease and is thus an important public health problem. Although some strains (genotypes) of the hepatitis C virus are highly responsive to treatment with a combination of peginterferon and ribavirin, the most common form of the virus (genotype 1) is relatively resistant to this treatment. [CONT.] Recruiting 240
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1.1 ClinicalTrials.Gov

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Trial Identifier
CR016678
VX-TiDP24-C219
NCT01054573
Trial Title
VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo
Original Title
An Open-label, Single-arm, Roll-over Trial of Telaprevir in Combination With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) for Subjects From the Control Group of the VX- 950-TiDP24-C216 Trial Who Failed Therapy for Virologic Reasons
Sponsor(s)
Tibotec BVBA
Vertex Pharmaceuticals Incorporated
Source
Tibotec BVBA
Oversight
Canada: Health Canada
Brief Summary
The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.
Detailed Description
This is an open-label (i.e all people involved know the identity of the intervention), single-arm, roll-over trial of telaprevir in combination with pegylated interferon (Peg-IFN) alfa-2a and ribavirin (RBV). The purpose of the trial is to provide access to telaprevir for patients who were randomized to the control group in the VX-950-TiDP24-C216 trial (referred to as C216 trial hereafter) and who failed therapy for virologic reasons. The efficacy, safety, and tolerability of telaprevir in combination with Peg IFN alfa 2a and RBV will be evaluated. In addition, amino acid changes from baseline in the HCV NS3 (i.e protein associated with the hepatitis C virus) protease domain will be evaluated. The trial will consist of a screening period of approximately 28 days, a 48-week treatment period, and a 24-week follow-up period. It is expected that approximately 120 patients could be eligible for enrollment. Since the C216 trial is blinded until all patients reach Week 72 (or have discontinued earlier), patients can only enter the current trial upon invitation. The investigator will receive an invitation sent by the unblinded independent virology monitor of the C216 trial for those patients of the C216 trial who were randomized to the control group and who failed therapy for virologic reasons. Next to this invitation, the patient will need to fulfill the inclusion and exclusion criteria of the current trial in order to be eligible to participate. The screening visit for the current trial can only occur after the patient completes all assessments in the C216 trial, including the Safety Follow-up Visit. Patients must not enter this trial later than 80 weeks after their first dose in the C216 trial. In the current trial, all patients will receive 12 weeks of telaprevir 750 mg every 8 hours (q8h) in combination with Peg-IFN alfa-2a and RBV at standard doses, i.e., 180 microgram once weekly and 1,000 or 1,200 mg/day (weight based), respectively, followed by 36 weeks of Peg IFN alfa 2a and RBV at standard doses. Patients with hepatitis C virus RNA levels < 25 IU/mL undetectable at the end of treatment (Week 48 or having discontinued earlier) will be followed for 24 weeks after the last dose of study medication to assess sustained virologic response (SVR). Safety/tolerability assessments will be performed and adverse events (AEs), regardless of severity, will be collected continuously until the Safety Follow-up Visit, scheduled 4 weeks after the last dose of study medication. Thereafter, only serious adverse events (SAEs) will be reported. All patients will receive 12 weeks of telaprevir 750 mg q8h (orally) in combination with Peg-IFN alfa-2a and RBV at standard doses, i.e., 180 microgram once weekly (injection) and 1,000 or 1,200 mg/day (weight-based) (orally), respectively, followed by 36 weeks of Peg IFN alfa-2a and RBV at standard doses.
Overall Status
Active, not recruiting
Start Date
March 2010
Completion Date
April 2012 (Anticipated)
Phase
Phase 3
Study Type
Interventional
Study Design
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
# Arms
1
Enrollment
90 (Actual)
Eligibility Criteria
Inclusion Criteria:

- Patient from the control group of the C216 study who failed therapy for virologic reasons

- Patient must have completed all assessments in the C216 trial

- Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication

Exclusion Criteria:

- Patient received any direct acting anti-viral HCV therapy after discontinuation of the C216 trial

- Patient has history of decompensated liver disease

- Patient has history of acute or chronic pancreatitis

- Patient has condition that requires use of systemic corticosteroids

- Patient who prematurely stopped medication for non-compliance or for whom it would be unsafe to repeat treatment

- Patient has history of decompensated liver disease or history of cirrhosis with hepatocellular carcinoma
Gender
Both
Minimum Age
18 Years
Maximum Age
70 Years
Healthy Volunteers?
No
Countries
United States
Argentina
Australia
Austria
Belgium
Brazil
Canada
France
Germany
Israel
Netherlands
Poland
Spain
Sweden
Switzerland
United Kingdom
Last Changed Date
2011-08-16
Interventions
NameTypeDescriptionGroup
Telaprevir/standard treatmentDrugTelaprevir 750 mg every 8h plus standard treatment. Standard treatment is 180 µg injection Peg-IFN alfa-2a and 1000-1200 mg twice daily RBV for 12 weeks, followed by 36 weeks of standard treatment001
Drugs
Telaprevir/standard treatment
Primary Outcome
Primary objective is to demonstrate the efficacy of telaprevir in combination with Peg-INF alfa-2a and RBV in patients from the control arm of the C216 study who failed therapy for virologic reasons.
Secondary Outcome
To evaluate amino acid changes from baseline in the HCV NS3 protease domain
To evaluate safety, and tolerability of telaprevir in combination with Peg IFN alfa 2a and RBV in these patients [Safety Issue]
Condition
Hepatitis C, Chronic
Overall Official
Tibotec Pharmaceuticals Clinical Trial
Study Director
Tibotec Pharmaceutical Limited
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Laurent COTTE, MD
Principal Investigator
Hopital Croix Rousse LYON FRANCE
Jean-Pierre ABOULKER, MD
Study Chair
INSERM SC10 VILLEJUIF FRANCE
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Num. Locations
51
Num. Recruiting
0

Information obtained from ClinicalTrials.gov on September 11, 2011

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Trial Title
An Open-label, Single-arm, Roll-over Trial of Telaprevir in Combination With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) for Subjects From the Control Group of the VX- 950-TiDP24-C216 Trial Who Failed Therapy for Virologic Reasons. Rollover study of VX- 950-TiDP24-C216.
Disease Type
HCV
Trial Phase
III
Patient Segment
Chronic hepatitis C
Genotype 1
Treatment experienced
Sponsorship
Johnson & Johnson/Janssen Biotech/Tibotec {J&J/Centocor Ortho Biotech/Tibotec Therapeutics {J&J/Ortho Biotech/Tibotec}}
Vertex
Primary Drugs
telaprevir
Other Drugs
peginterferon alfa-2a (SC)
ribavirin, Roche
Trial Identifier
CR016678
EudraCT Number:2009-012613-21
NCT01054573
Rollover study of VX- 950-TiDP24-C216
TiDP24-C219
TrialTroveID-121715
VX-950-TiDP24-C219
VX-TiDP24-C219
VX950-TiPD24-C219
Trial Status
Closed
Trial Objectives
To provide access to telaprevir for patients who were randomized to the control group in the VX-950-TiDP24-C216 trial (referred to as C216 trial hereafter) and who failed therapy for virologic reasons. To evaluate the efficacy, safety, and tolerability of telaprevir in combination with Peg IFN alfa 2a and RBV. In addition, amino acid changes from baseline in the HCV NS3 (i.e protein associated with the hepatitis C virus) protease domain will be evaluated.
Primary Endpoints
Primary Outcome Measures: Primary objective is to demonstrate the efficacy of telaprevir in combination with Peg-INF alfa-2a and RBV in patients from the control arm of the C216 study who failed therapy for virologic reasons. [Time Frame: 24 weeks after last intake of study medication (FU week 24)] [Designated as safety issue: No]. Primary End Point: NAP
Other Endpoints
Secondary Outcome Measures: - To evaluate safety, and tolerability of telaprevir in combination with Peg IFN alfa 2a and RBV in these patients [Time Frame: at DB lock, i.e 10-May-2012] [Designated as safety issue: Yes]. - To evaluate amino acid changes from baseline in the HCV NS3 protease domain [Time Frame: screening, W4-W8-W12-W24-W36-W48-EOT-FU4-FU24] [Designated as safety issue: No].
Start Date
2010-03-01
Primary Endpoints Reported
2012-04-01
Patient Population
Patients with Chronic Hepatitis C.
Inclusion Criteria
Ages Eligible for Study: 18 Years to 70 Years Inclusion Criteria: - Patient from the control group of the C216 study who failed therapy for virologic reasons. - Patient must have completed all assessments in the C216 trial. - Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication. - Subjects with cirrhosis should have serum alpha-fetoprotein (AFT) < or = 50 ng/mL. - Subject is willing and able to refrain from the concomitant use of any medications, substances, or foods disallowed. - Subject is judged to be in good health (besides HCV infection) in the opinion of the investigator, on the basis of medical history, physical examination, screening vital signs, screening electrocardiogram [ECG], and screening laboratory tests, with any chronic medical conditions under stable medical control. - If heterosexually active, a female subject of childbearing potential and a non-vasectomized male subject who has a female partner of childbearing potential must agree to the use of 2 effective methods of contraception from screening onwards until 6 months (female subject) or 7 months (male subject) after the last dose of RBV Note: Male subjects should use a male condom. This birth control method should be combined with another effective method such as hormonal contraceptives (like the patch, or the pill), intrauterine device, diaphragm with spermicidal jelly or cervical cap. Note: Hormonal contraceptives may not be reliable when taking telaprevir. Therefore, to be eligible for this trial, subjects should use 2 other effective birth control methods during telaprevir treatment and for 2 months after the last intake of telaprevir. As of 2 months after completion of telaprevir treatment, hormonal contraceptives can again be used as one of the 2 required effective methods of birth control. Note: The use of birth control methods does not apply if the male partners have been vasectomized minimally 1 month prior to screening or if the female partners have had a bilateral oophorectomy, a total hysterectomy, or tubal ligation, or if they have been post-menopausal for at least 2 years. - Subject is able to read and understand, and is willing to sign the ICF voluntarily before first trial-related activity and abide by the trial restrictions. - Subjects should agree not to participate in other clinical trials for the duration of his/her participation in this trial, except for non-interventional or observational trials and after prior approval of the sponsor.
Exclusion Criteria
Exclusion Criteria: - Patient received any direct acting anti-viral HCV therapy after discontinuation of the C216 trial. - Patient has history of decompensated liver disease: - history of ascites, hepatic encephalopathy, or bleeding esophageal varices, and/or any of the following screening laboratory results: - International Normalized Ratio (INR) of > or =1.5. - Serum albumin < 3.3 g/dL. - Serum total bilirubin > 1.8 times upper limit of laboratory normal range (ULN), unless isolated (i.e., only occurring at a single time point and/or not associated with other clinically relevant laboratory abnormalities) or in subjects with Gilbert's Syndrome. - Patient has history of acute or chronic pancreatitis. - Patient has condition that requires use of systemic corticosteroids. - Patient who prematurely stopped medication for non-compliance or for whom it would be unsafe to repeat treatment. - Patient has history of decompensated liver disease or history of cirrhosis with hepatocellular carcinoma. For subjects with cirrhosis, AFP level will be measured and an abdominal ultrasound will be performed in order to screen for hepatocellular carcinoma. In case of AFP > 50 ng/mL or ultrasound being abnormal, subjects must also have a CT or MRI scan to exclude hepatocellular carcinoma. Assessments of the AFP level and ultrasounds (and CT or MRI scans if necessary) will be performed at screening, unless these assessments have been performed in the C216 trial within 6 months prior to screening in the current trial. - Subjects who stopped study medication in the C216 study early because of an adverse event considered related or possibly related to the study medication. - Subject has developed any contradiction to the administration of Peg-IFN alfa-2a or RBV - Hypersensitivity to Peg-IFN alfa-2a, RBV, or any of their components - Newly acquired hemoglobinopathies - History or clinical evidence of significant or unstable cardiac disease (e.g. angina, congestive heart failure, recent myocardial infarction, significant arrhythmia) and/or clinically significant ECG abnormalities - Abnormal thyroid function that is not controlled effectively by medication - Eye abnormalities at the recommended pretreatment opthalmological clearance - Creatinine clearance < or =50 mL/min at screening - Evidence of autoimmune condition. - Subject has pre-existing psychiatric condition. - Subject has history of seizure disorders. - Subject has history of organ transplant that requires chronic immunosuppression. - Diabetic or hypertensive subject with clinically significant ocular exam findings. - Subject has history or other clinical evidence of chronic pulmonary disease associated with functional impairment. - Subject has hemophilia. - Subject has evidence of serious or severe bacterial or fungal infection(s - Subject has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection. - Subject has a history of acute or chronic pancreatitis. - Subject or female partner is pregnant, planning to become pregnant, or breastfeeding. - Subject has abnormal liver enzymes that do not meet acceptable values for hepatitis C studies. - Subject received any direct acting anti-viral HCV therapy after discontinuation of the C216 trial. - Subject has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma). - Diabetic or hypertensive subject with clinically significant ocular exam findings, e.g., retinopathy, cotton wool spots, and optic nerve disorder. Clearance by an ophthalmologist is required within 3 months prior to screening or within the screening period. The ophthalmologist should conduct a fundoscopic exam, which should be documented in the subjects' records. The findings of the exam must also be recorded on the eCRF. - Suspicion exists of alcohol, barbiturate, or amphetamine recreational or narcotic drug use, current or within 2 years prior to the screening visit, that in the investigator's opinion would compromise the subject's safety and/or compliance with study procedures. - Subject has any clinically significant laboratory abnormalities as judged by the investigator, with the following exceptions: - Grade 3 elevations in transaminsases ([ALT], [AST]). However, ALT/AST levels at screening should not exceed 10 times ULN. - Grade 3 elevations in GGT. However, subjects with grade 3 GGT elevations will only be allowed to enter the trial if there is no evidence of current alcohol abuse and if the GGT elevations are not associated with other clinically relevant laboratory abnormalities, as judged by the investigator. - Subject has screening laboratory values of the following variables that do not meet the acceptable values defined below: Absolute neutrophil count - 1,200/mm^3, Platelet count - 90,000/mm^3, Hemoglobin - 12 g/dL for females - 13 g/dL for males, Thyroid-stimulating hormone (TSH) Within normal range, or adequately controlled thyroid function on treatment
Gender
Both
Age (Min)
18
Age (Min) Units
Years
Age (Max)
70
Age (Max) Units
Years
Prior/Concurrent Therapy
N/A
Target Accrual
120 (12 subjects in France, 4 subjects in Italy, 50 subjects in Europe)
Reported Sites
51
Identified Sites
6
Actual Accrual
90
Trial Locations
Argentina
Australia
Austria
Belgium
Brazil
Canada
France
Germany
Israel
Italy
Netherlands
Poland
Puerto Rico
Spain
Sweden
Switzerland
UK
US
Treatment Plan
N/A
Study Keywords
interventional open label single group assignment safety/efficacy single arm uncontrolled non randomized
Study Design
Study Type: Interventional Study Design: Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment This is a single-arm, roll-over study. This is an uncontrolled, non randomized study.
Investigators / Contacts
Paul Kwo, Primary Investigator, Indiana University Carolyn Adams, Indiana University Phone: 317-278-1187 E-mail: hepstudy@iupui.edu Gregory T. Everson, M.D., F.A.C.P., Professor of Medicine, Director, Section of hepatology, Division of gastroenterology, University of Colorado school of medicine, Transplant center & hepatology clinic, b154, University of, Colorado Hospital AOP, room 7085 1635 Aurora CT. B154, P.O Box 6510, Aurora, Colorado 80045 Phone: (303) 724-1857 Fax: (720) 848-2246 Tibotec-Virco Virology BVBA Clinical Trial, Study Director, Tibotec BVBA Compound Development Team Leader, Responsible Party, Tibotec Pharmaceuticals, Ireland Contact: E-mail: info1@veritasmedicine.com E-mail: JNJ.CT@sylogent.com Dr.Peter Ferencix, Univ.Prof, Clinic: Univ.Klin.f. Internal Medicine III, Klin.Abt.f. Gastroenterology and Hepatology
Notes
Locations/Contacts Study sites and Contact information (Last Updated on August 16, 2011) [Last accessed on August 19, 2011] United States, California Coronado, California, United States Los Angeles, California, United States San Francisco, California, United States United States, Florida Bradenton, Florida, United States Miami, Florida, United States United States, Georgia Atlanta, Georgia, United States United States, Indiana Indianapolis, Indiana, United States United States, Missouri Kansas City, Missouri, United States United States, New York New York, New York, United States United States, North Carolina Chapel Hill, North Carolina, United States United States, Pennsylvania Philadelphia, Pennsylvania, United States United States, South Carolina Columbia, South Carolina, United States United States, Texas Houston, Texas, United States San Antonio, Texas, United States Australia Adelaide, Australia Clayton, Australia Darlinghurst, Australia Perth, Australia Austria Wien, Austria Belgium Brussels, Belgium Gent, Belgium Leuven, Belgium Brazil Distrito Barao Geraldo-Campina, Brazil Salvador, Brazil Sao Paulo, Brazil Canada, Quebec Montreal, Quebec, Canada France Clichy, France Créteil, France Lille Cedex, France Paris, France Pessac, France Germany Berlin, Germany Frankfurt, Germany Hamburg, Germany Hannover, Germany Köln, Germany München, Germany Israel Petah Tiqva, Israel Zefat, Israel Netherlands Amsterdam, Netherlands Nijmegen, Netherlands Poland Bialystok, Poland Czeladz, Poland Warszawa, Poland Puerto Rico San Juan, Puerto Rico Spain Barcelona, Spain Madrid, Spain Valencia, Spain Sweden Stockholm, Sweden Switzerland Zurich N/A, Switzerland United Kingdom London, United Kingdom http://clinicaltrials.gov/ct2/show/study/NCT01054573

Study Timing Study Start Date: March 2010 Estimated Study Completion Date: April 2012 Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure) http://clinicaltrials.gov/ct2/show/study/NCT01054573

Excerpted from: Uniklinik Koln [Translated from German] [Accessed on July 02, 2011]: Gastroenterological studies hepatological ...Indication: Chronic hepatitis C protocol number: VX950-TiPD24-C219 Study Title: "An open, single-arm extension study with telaprevir in combination with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) for patients in the control group, the clinical examination VX950-TiPD24 -C216, where the therapy has failed for virological reasons, " [dt. An open-label single-arm, roll-over trial of telaprevir in combination with Pegasys and Copegus for subjects from the control group of the VX950-C216 trial who failed therapy due to virologic reasons]... ...Indikation: chronische Hepatitis C Protokoll-Nummer: VX950-TiPD24-C219 Studientitel: "Eine offene, einarmige Folgestudie mit Telaprevir in Kombination mit pegyliertem Interferon alfa-2a (Pegasys) und Ribavirin (Copegus) für Patienten der Kontrollgruppe der klinischen Prüfung VX950-TiPD24-C216, bei denen die Therapie aus virologischen Gründen versagt hat" [engl.: An open-label, single-arm, roll-over trial of Telaprevir in combination with Pegasys and Copegus for subjects from the control group of the VX950-C216 trial who failed therapy due to virologic reasons]... http://gastroenterologie-hepatologie.uk-koeln.de/klinische-studien-1/patienten-mit-chronischer-hepatitis-c-oder-b http://translate.google.com/translate?hl=en&sl=de&tl=en&u=http%3A%2F%2Fgastroenterologie-hepatologie.uk-koeln.de%2Fklinische-studien-1%2Fpatienten-mit-chronischer-hepatitis-c-oder-b

Excerpted from: CURRICULUM VITAE GREGORY T. EVERSON, M.D., F.A.C.P. PROFESSOR OF MEDICINE DIRECTOR, SECTION OF HEPATOLOGY DIVISION OF GASTROENTEROLOGY UNIVERSITY OF COLORADO SCHOOL OF MEDICINE TRANSPLANT CENTER & HEPATOLOGY CLINIC, B154 UNIVERSITY OF COLORADO HOSPITAL AOP, ROOM 7085 1635 AURORA CT. B154 P.O. BOX 6510 AURORA, COLORADO 80045 PHONE: (303) 724-1857 FAX: (720) 848-2246 Page#: 20 Pending Research Support An open-label, single-arm, roll-over trial of telaprevir in combination with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) for subjects from the control group of the VX-950-TiDP24-C216 trial who failed therapy for virologic reasons - TiDP24-C219 (Tibotec), March 2010. http://www.cusomgateway.com/uploaded-provider-files/2241/Everson%20CV2.doc

EU Clinical Trials Register: [accessed on April 06, 2011]: Protocol Information: EudraCT Number: 2009-012613-21 Sponsor's Protocol Code Number: VX-950-TiDP24-C219 National Competent Authority: Netherlands - Competent Authority Clinical Trial Type: EEA CTA Trial Status: Ongoing Full title of the trial: An open-label, single-arm, roll-over trial of telaprevir in combination with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) for subjects from the control group of the VX-950-TiDP24-C216 trial who failed therapy for virologic reasons Sponsor's protocol code number: Sponsor Information: Name of Sponsor: Tibotec BVBA Trial contains a sub-study: No Number of sites anticipated in Member State concerned: 1 The trial involves multiple Member States: Yes Number of sites anticipated in the EEA: 44 Initial estimate of the duration of the trial In the Member State concerned years: 1 In the Member State concerned months: 5 In the Member State concerned days: 14 In all countries concerned by the trial years: 1 In all countries concerned by the trial months: 5 In all countries concerned by the trial days: 14 Planned number of subjects to be included In the member state: 1 In the EEA: 61 In the whole clinical trial: 120 Search with '2009-012613-21' at: https://www.clinicaltrialsregister.eu/ctr-search/

Excerpted from: Fundacion De Investigacion [Accessed on March 3, 2011] Upcoming studies Hepatatis C Type: "An open-label, single-arm, roll-over trial of telaprevir in combination with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) for subjects from the control group of the VX 950 TiDP24 C216 trial who failed therapy for virologic reasons" Status: To be Closed [The URL has expired] http://www.fundacionpr.com/eng/patients/studies%201.html

Excerpted from: French Agency for the Safety of Health Products [Accessed on April 06, 2011] [Translated from French] Test Description Full track: An open-label, single-arm, roll-over trial of telaprevir in combination With pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) for control subjects From The Group Of The VX-950-C216-trial TiDP24 Who failed therapy for virologic Reasons Current status of trial: Ongoing [More information about the trial] Disease (s) or condition (s) (s) concerned by the test: chronic hepatitis C genotype 1 infection Rare disease: No [View MedDRA codes] Drug (s) experienced (s) [Tabular data is available] [View (s) comparator (s) for the comparative tests, where appropriate] Persons undergoing testing: studied age (s): 18 to 65 years and Over 65 years Sex: Men and Women [More information about the persons undergoing the test] Proponent Information: Name: Tibotec BVBA Status: Commercial Address: Generaal De Wittelaan L11 B3 Postal Code: 2800 City: Mechelen Country: BELGIUM [Original text] Description de l'essai Titre complet An open-label, single-arm, roll-over trial of telaprevir in combination with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) for subjects from the control group of the VX-950-TiDP24-C216 trial who failed therapy for virologic reasons Etat d'avancement de l'essai : En cours [Plus d'informations sur l'essai] Maladie(s) ou affection(s) concernée(s) par l'essai: chronic genotype 1 hepatitis C infection Maladie rare: Non [Voir les codes MedDRA] Médicament(s) expérimenté(s) [Tabular data is available] [Voir le(s) comparateur(s) pour les essais comparatifs, le cas échéant] Personnes se prêtant à l'essai: Tranche(s) d'âge étudiée(s): De 18 à 65 ans and Plus de 65 ans Sexe: Hommes and Femmes [Plus d'informations sur les personnes se prêtant à l'essai] Information sur le promoteur Nom : Tibotec BVBA Statut : commercial Adresse : Generaal De Wittelaan L11 B3 Code Postal : 2800 Ville : Mechelen Pays : BELGIQUE https://icrepec.afssaps.fr/Public/essai.php?num=2009-012613-21

Excerpted from DIRECTORY OF PUBLIC authorized clinical trials: [Accessed on April 06, 2011] [Translated from French] 1. Full title of biomedical research Study of roll-over, open, single arm, with telaprevir in combination with peginterferon alfa-2a (Pegasys) and ribavirin (Copegus) for patients in the control group of VX-950-test-TiDP24 C216 who are failing treatment virological reasons. 2. Short title and easily understandable Research Follow-up study TiDP24-VX950-C216 for patients in the placebo arm in treatment failure. 3. Medical condition or disease being studied Hepatitis C virus (HCV) infection, genotype 1 4. Brief description of research easily understandable This is a study of''rollover''in open, single arm, with telaprevir (VX-950) in combination with peginterferon alfa-2a (Pegasys) and Ribavirin (Copegus) . The objective of the trial is to provide access to telaprevir in patients with hepatitis C, genotype 1, who were in the control group test VX-950-C216-TIDP24 and are in treatment failure for reasons virology. About 120 patients may be eligible for this trial. All trial patients C219 will receive: - For 12 weeks, the dose of telaprevir 750 mg every 8 hours, together with the usual treatment (Interferon and Ribavirin) - Then the usual treatment for 36 weeks. total duration of 48 weeks treatment. 5. List of countries in which it is intended to include people in research Austria, Belgium, France, Poland, Germany, Italy, Spain, Sweden, Switzerland, the Netherlands, the United Kingdom, Canada, United States, the Argentina, Australia, Brazil, Israel 6. Origin of research funding Organization Name Tibotec BVBA Country Belgium 7. Contact Information in France designated the developer for questions about research Proponent Name Tibotec BVBA Contact Name medisource Email Contact medisource@its.jnj.com [Original text] REPERTOIRE PUBLIC DES ESSAIS CLINIQUES AUTORISES 1. Titre complet de la recherche biomédicale Etude de roll-over, en ouvert, simple bras, avec le télaprevir en association avec le peginterféron alfa-2a (Pegasys) et la ribavirine (Copegus) destinée aux patients du groupe contrôle de l'essai VX-950-TiDP24-C216 qui sont en échec de traitement pour des raisons virologiques. 2. Titre abrégé et facilement compréhensible de la recherche Suivi de l’étude VX950-TiDP24-C216 pour les patients du bras placebo en échec de traitement. 3. Condition médicale ou pathologie étudiée Virus de l’hépatite C (VHC) chronique, de génotype 1 4. Brève description facilement compréhensible de la recherche Il s’agit d’une étude de ‘’roll-over’’, en ouvert, simple bras, avec le télaprevir (VX-950) en association avec le peginterféron alfa-2a (Pegasys) et la Ribavirine (Copegus). L’objectif de l’essai est de donner accès au télaprevir aux patients présentant une hépatite C, de génotype 1, qui étaient dans le groupe contrôle de l’essai VX-950-TIDP24-C216 et qui sont en échec thérapeutique pour des raisons virologiques. Environ 120 patients peuvent être éligibles pour cet essai. Tous les patients de l’essai C219 recevront : - pendant 12 semaines, le télaprevir à la dose de 750 mg toutes les 8 heures, en association avec le traitement habituel (Interféron et Ribavirine) - puis le traitement habituel pendant 36 semaines. soit une durée totale de traitement de 48 semaines. 5. Liste des pays dans lesquels il est prévu d’inclure des personnes dans la recherche L'Autriche, la Belgique, la France, la Pologne, l’Allemagne, l’Italie, l’Espagne, la Suède, la Suisse, les Pays Bas, le Royaume-Uni, le Canada, Les Etats-Unis, l’Argentine, l’Australie, le Brésil, l’Israël 6. Origine du financement de la recherche Nom de l’organisme Tibotec BVBA Pays Belgique 7. Coordonnées du contact en France désigné par le promoteur pour toute question sur la recherche Nom du promoteur Tibotec BVBA Nom du contact medisource Adresse électronique du contact medisource@its.jnj.com https://icrepec.afssaps.fr/Public/download.php?file=2009-012613-21_DESC.pdf

Excerpted from: Ricerca-Clinica [Portal of Clinical Research With Medicines in Italy] [Accessed on April 06, 2011] [Translated from Italian] Study of roll-over in open single-arm telaprevir combined with peginterferon alfa-2a (Pegasys) and ribavirin (Copegus) in patients in the control group study VX-950-C216-TiDP24 for whom treatment and ' ineffective for reasons of virological The study is: Open This is a study of multi- Number of planned centers in Italy: 3 Number of planned centers in Europe: 37 Life Expectancy for entry into Italy: 6 Months Expected duration of the study in its entirety in Italy: 22 Months Expected duration of the study in its entirety in the world: 26 Months Countries where testing is carried out: Italy, European Union and other countries outside Europe Projected population: 4 subjects in Italy, Europe in 50 subjects, 120 subjects in the world [Original Text] Studio di roll-over in aperto a braccio singolo su telaprevir associato a interferone pegilato alfa-2a (Pegasys) e ribavirina (Copegus) in soggetti appartenenti al gruppo di controllo dello studio VX-950-TiDP24-C216 per i quali la terapia e' risultata inefficace per motivi virologici Lo studio è: Aperto Si tratta di uno studio multicentrico Numero di centri previsti in Italia: 3 Numero di centri previsti in Europa: 37 Durata prevista per l'arruolamento in Italia: 6 Mesi Durata prevista dello studio in toto in Italia: 22 Mesi Durata prevista dello studio in toto nel mondo: 26 Mesi Paesi in cui viene svolta la sperimentazione: Italia, Unione Europea ed altri paesi extra europei Popolazione prevista: 4 soggetti in Italia, 50 soggetti in Europa, 120 soggetti nel mondo http://ricerca-clinica.agenziafarmaco.it/en/node/index.php?q=node/150&Cerca=studio&ID_STUD=47598&TIPOLOGIA=1&RICERCA_LIBERA=2009-012613-21

Excerpted from: Indiana University [Accessed on April 06, 2011]: Actively Enrolling: Yes Primary Investigator: Kwo,Paul Title: An Open-Labled, Single-Arm, Roll-Over Trial of telaprevir in Combination with Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) for Subjects from the Control Group of the VX-950-TiDP24-C216 Trial Who Failed Therapy for Virologic Reasons Date PublishedOctober 25th, 2010 Contact Name: Carolyn Adams Contact Phone: 317-278-1187 Compensation: Yes Disease: Hepatitis Healthy Volunteers: No Inclusion / Exclusion: Inclusion criteria: 1. Subject was randomized to the VX-950-TiDP24-C216 control group (Group C) and did not achieve SVR. 2. Subjects with cirrhosis should have serum alpha-fetoprotein (AFT) = 50 ng/mL. 3. If heterosexually active, a female subject of childbearing potentia...Inclusion criteria: 1. Subject was randomized to the VX-950-TiDP24-C216 control group (Group C) and did not achieve SVR. 2. Subjects with cirrhosis should have serum alpha-fetoprotein (AFT) = 50 ng/mL. 3. If heterosexually active, a female subject of childbearing potential and a non-vasectomized male subject who has a female partner of childbearing potential must agree to the use of 2 effective methods of contraception from screening onwards until 6 months (female) or 7 months (male) after the last dose of RBV. 4. Subject is willing and able to refrain from the concomitant use of any medications, substances, or foods disallowed. Exclusion criteria 1. Subjects who stopped study medication in the C216 study early because of an adverse event considered related or possibly related to the study medication. 2. Subject has developed any contradiction to the administration of Peg-IFN alfa-2a or RBV 3. Subject has pre-existing psychiatric condition. 4. Subject has history of decompensated liver disease. 5. Subject shows evidence of significant liver disease in addition to hepatitis C. 6. Subject has active malignant disease or history of malignant disease within the past 5 years 7. Subject has history of seizure disorders. 8. Subject has history of organ transplant that requires chronic immunosuppression. 9. Subject has medical condition that requires use of systemic corticosteroids 10. Diabetic or hypertensive subject with clinically significant ocular exam findings. 11. Subject has history or other clinical evidence of chronic pulmonary disease associated with functional impairment. 12. Subject has hemophilia. 13. Subject has evidence of serious or severe bacterial or fungal infection(s 14. Subject has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection. 15. Subject has a history of acute or chronic pancreatitis. 16. Subject or female partner is pregnant, planning to become pregnant, or breastfeeding. 17. Subject has abnormal liver enzymes that do not meet acceptable values for hepatitis C studies. Less [The URL has expired] http://www.indianactsi.org/clinicaltrial/?task=displayOne&id=41468 http://www.indianactsi.org/clinicaltrial/?task=displayOne&id=63584

September 23, 2010 [Translated from German] Excerpted from: Applications 2010 EC-No. 2010/088 Project Title: An open-label, single-arm, roll-over trial of telaprevir in combination with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) for subjects from the control group of the VX-950-TiDP24-C216 trial who failed therapy for virologic reasons. Applicants: Univ.Prof.Dr.Peter Ferencix Clinic: Univ.Klin.f. Internal Medicine III, Klin.Abt.f. Gastroenterology and Hepatology Sponsor: Tibotec BVBA, Janssen-Cilag Pharma GmbH Additional centers: Med. Univ. Graz, Wilhelminenspital Page 11 of PDF at: http://ethikkommission.meduniwien.ac.at/fileadmin/ethik/media/dokumente/register/alle_2010.pdf

January 26, 2010 According to Johnson and Johnson selected Pharmaceuticals in Late stage U.S and E.U. Development or Registration telaprevir an Anti-viral is in Phase III clinical development in Europe for Chronic hepatitis C virus (HCV) infection. http://files.shareholder.com/downloads/JNJ/836066652x0x345048/f43507f5-0f3a-48b5-a101-98e2b79ec03a/Q42009pipeline.pdf

Refer to TrialTroveID-90049 for the primary study. NCT00703118: A Randomized, Double-blind, Placebo-controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic, Genotype 1, Hepatitis C Infection Who Failed Prior Standard Treatment (VX-950-TiDP24-C216). http://www.clinicaltrials.gov/ct2/show/NCT00703118

Excerpted from: Vertex - Development Pipeline [Last Revised 02/22/10] HCV Infection Telaprevir (VX-950), Jannssen, Mitsubishi Phase 3 http://www.vrtx.com/current-projects.html
Supporting URLs
http://ethikkommission.meduniwien.ac.at/fileadmin/ethik/media/dokumente/register/alle_2010.pdf
http://files.shareholder.com/downloads/JNJ/836066652x0x345048/f43507f5-0f3a-48b5-a101-98e2b79ec03a/Q42009pipeline.pdf
http://gastroenterologie-hepatologie.uk-koeln.de/klinische-studien-1/patienten-mit-chronischer-hepatitis-c-oder-b
http://oss-sper-clin.agenziafarmaco.it/cgi-bin/ossc_view_pub?CODICE_PROT=VX-950-TiDP24-C219&TITOLO_PROT=&FILE=scheda_part_pub&AZIONEFORM=VIEW&ID_SPER=47598&
http://ricerca-clinica.agenziafarmaco.it/en/node/index.php?q=node/150&&Cerca=centri&&ID_STUD=47598&&TIPOLOGIA=1
http://ricerca-clinica.agenziafarmaco.it/en/node/index.php?q=node/150&Cerca=studio&ID_STUD=47598&TIPOLOGIA=1&RICERCA_LIBERA=2009-012613-21
http://translate.google.com/translate?hl=en&sl=de&tl=en&u=http%3A%2F%2Fgastroenterologie-hepatologie.uk-koeln.de%2Fklinische-studien-1%2Fpatienten-mit-chronischer-hepatitis-c-oder-b
http://www.clinicaltrials.gov/ct2/show/NCT01054573
http://www.cusomgateway.com/uploaded-provider-files/2241/Everson%20CV2.doc
http://www.indianactsi.org/clinicaltrial/?task=displayOne&id=63584
http://www.vrtx.com/current-projects.html
https://icrepec.afssaps.fr/Public/download.php?file=2009-012613-21_DESC.pdf
https://icrepec.afssaps.fr/Public/essai.php?num=2009-012613-21
https://www.clinicaltrialsregister.eu/ctr-search/
Last Modified
2011-08-19
Last Full Review
2011-04-06
Internal Comments
N/A
Record URL
http://jnj.citeline.com/xt_view.asp?trialid=121715&target=10
Record Number
121715
Drug Name(s)
telaprevir
peginterferon alfa-2a (SC)
ribavirin, Roche

© 2002-2011 Citeline Inc. All rights reserved. This information is subject to a TrialTrove license agreement. See www.citeline.com/subscriptionlicense.html.

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An Open-label, Single-arm, Roll-over Trial of Telaprevir in Combination With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) for Subjects From the Control Group of the VX- 950-TiDP24-C216 Trial Who Failed Therapy for Virologic Reasons.
700053070


Study Details
Purpose
This trial will assess the efficacy of telaprevir [Vertex Pharmaceuticals] + peginterferon alfa 2a [Pegasys] + ribavirin [Copegus] in patients with hepatitis C. The primary endpoint is efficacy. This will be assessed at 24 weeks.
Start Date: 01 Mar 2010 (actual)
End Date: 01 Apr 2012 (planned)

Details Study Design: multicentre, open, prospective
Study Controls: baseline comparison
Study Status: Active, no longer recruiting
Study Phase: III
Study Location: Argentina Australia Austria Belgium Brazil Canada England France Germany Israel Multinational Netherlands Poland Puerto Rico Spain Swaziland Sweden Switzerland USA
Study Endpoint: Laboratory parameters, Virological response

Subjects Type: patients
Number: 90
Age: 18-70 years, adult, elderly

Patient Inclusion: Aged 18-70 years; patient from the control group of the C216 study who failed therapy for virologic reasons - Patient must have completed all assessments in the C216 trial - Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication.
Patient Exclusion: Patient received any direct acting anti-viral HCV therapy after discontinuation of the C216 trial - Patient has history of decompensated liver disease - Patient has history of acute or chronic pancreatitis - Patient has condition that requires use of systemic corticosteroids - Patient who prematurely stopped medication for non-compliance or for whom it would be unsafe to repeat treatment - Patient has history of decompensated liver disease or history of cirrhosis with hepatocellular carcinoma.

Study Centre Details
NameCountryInvestigatorsContact Details
   E-mail: info1@veritasmedicine.com
Johnson and Johnson Pharmaceutical Research and Development  
Tibotec PharmaceuticalsIreland 
Vertex Pharmaceuticals Incorporated   

Study Status History
DateEventCommentUpdate Date
30/08/2011Other trial eventProfile reviewed.30/08/2011
16/08/2011Other trial eventLast checked against ClinicalTrials.gov record.30/08/2011
01/04/2011Status change - active, no longer recruitingStatus changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.21/04/2011
07/10/2010Completion datePlanned end date changed from Mar 2012 to Apr 2012 as reported by ClinicalTrials.gov.14/10/2010
27/03/2010Other trial eventActual start date (1 Mar 2010) and additional trial locations added as reported by ClinicalTrials.gov.29/03/2010
27/03/2010Status change - recruitingStatus changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov.29/03/2010
30/01/2010New trial recordNew trial record30/01/2010

Disease Treated
IndicationPatient Segment
Hepatitis-Cchronic
Hepatitis-Csecond-line-or-greater therapy

Treatments
NameDoseRouteFreqDur.
Peginterferon alfa 2a180 µg/weekinj1/week48 weeks
Ribavirin1000-2000 mg/dayPObid48 weeks
Telaprevir2250 mg/day tid12 weeks


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Trial Identifier
VX09-222-103
NCT01080222
Trial Title
A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection
Original Title
A Randomized, Parallel-Group, Dose-Ranging Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Antiviral Activity of VX-222 and Telaprevir in Combination With and Without Peginterferon-Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C
Sponsor(s)
Vertex Pharmaceuticals Incorporated
Source
Vertex Pharmaceuticals Incorporated
Oversight
New Zealand: Medsafe
United States: Food and Drug Administration
Brief Summary
The purpose of this study is to assess the safety and efficacy of combination treatment with VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and/or ribavirin. The subjects enrolled in this study are chronically infected with hepatitis C virus (HCV) genotype 1 and will not have previously received treatment for their HCV infection.

This study will include an Investigational Phase and Extension Phase. These phases will contain a Treatment Period and a Follow-up Period. All subjects will be enrolled in the Investigational Phase of this study. Subjects who fail treatment during the Investigational Phase will have the option to enter the Extension Phase at which point they will be eligible to receive peginterferon alfa-2a and ribavirin for a total of 48 weeks.

Based on an evaluation of on-treatment safety, pharmacokinetic and antiviral data from patients in each arm of the trial, Vertex may elect to enroll up to two additional treatment arms (Treatment Arm E and Treatment Arm F) that will evaluate telaprevir/VX-222-based combination therapy. The components of the treatment regimens of these arms will be selected based on clinical data that emerges from the four initially-studied regimens. If enacted, up to 25 patients are expected to enroll in each additional treatment arm.

If Treatment Arm E or Treatment Arm F is discontinued subjects meeting certain criteria will have the option to enter a telaprevir-containing Rollover Phase. Subjects who do not meet the eligibility criteria to enter the Rollover Phase may elect to enter the Extension Phase.
Overall Status
Recruiting
Start Date
August 2010
Completion Date
September 2011 (Anticipated)
Phase
Phase 2
Study Type
Interventional
Study Design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
# Arms
6
Enrollment
150 (Anticipated)
Eligibility Criteria
Inclusion Criteria:

- Males and females of non-childbearing potential

- Genotype 1 chronic hepatitis C

- Laboratory evidence of HCV infection for 6 months

- Histologic evidence of chronic hepatitis C

- Subjects who have a body mass index (BMI) of ≤35 kg/m² (BMI = weight in kg / height² in meters)

- Treatment Arm E: This arm will enroll only subjects infected with HCV genotype 1b virus

- Treatment Arm F: This arm will enroll only subjects infected with HCV genotype 1a virus

Exclusion Criteria:

- Subjects who have received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C

- Subjects with any contraindications to peginterferon alfa-2a and/or ribavirin

- Subjects with any other cause of significant liver disease in addition to hepatitis C, which may include, but is not limited to malignancy with hepatic involvement, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis (NASH), or primary biliary cirrhosis

- Histologic evidence of hepatic cirrhosis
Gender
Both
Minimum Age
18 Years
Maximum Age
65 Years
Healthy Volunteers?
No
Countries
United States
New Zealand
Last Changed Date
2011-07-11
Interventions
NameTypeDescriptionGroup
telaprevirDrugtablet, 1125-mg, twice dailyTreatment Arm A
Treatment Arm B
Treatment Arm C
Treatment Arm D
Treatment Arm E
Treatment Arm F
VX-222Drugcapsule, 100-mg, twice dailyTreatment Arm A
Treatment Arm C
ribavirinDrugtablet, 1000-mg for subjects weighing <75-kg or 1200-mg for subjects weighing ≥75-kg, twice dailyTreatment Arm C
Treatment Arm D
Treatment Arm E
Treatment Arm F
peginterferon-alfa-2aBiologicalsubcutaneous injection, 180-mcg, once weeklyTreatment Arm C
Treatment Arm D
VX-222Drugcapsule, 400-mg, twice dailyTreatment Arm B
Treatment Arm D
Treatment Arm E
Treatment Arm F
Drugs
telaprevir
VX-222
ribavirin
Primary Outcome
Safety and Tolerability [Safety Issue]
Secondary Outcome
Proportion of Subjects Who Achieve a Sustained Viral Response
Undetectable HCV RNA Measurements
Proportion of Subjects Who Have a Viral Breakthrough or Relapse
Plasma Exposures of VX-222 and Telaprevir
Condition
Chronic Hepatitis C Virus Infection
Overall Official
Tibotec Pharmaceuticals Clinical Trial
Study Director
Tibotec Pharmaceutical Limited
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Laurent COTTE, MD
Principal Investigator
Hopital Croix Rousse LYON FRANCE
Jean-Pierre ABOULKER, MD
Study Chair
INSERM SC10 VILLEJUIF FRANCE
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Michael Adler, MD, PhD
Principal Investigator
Erasmus Hospital Bruxelles
Hendrik Reesink, MD, PhD
Principal Investigator
Academic Medical Center of the University of Amsterdam
Kenneth Sherman, MD, PhD
Principal Investigator
University of Cincinnati
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Tadashi Yoshida, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Nathalie Adda, MD
Study Director
Vertex Pharmaceuticals Incorporated
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Andrew H. Talal, MD, MPH
Principal Investigator
Weill Medical College of Cornell University
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Tadashi Yoshida, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Steven Lidofsky, MD
Principal Investigator
University of Vermont & Fletcher Allen Health Care
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Num. Locations
21
Num. Recruiting
14

Information obtained from ClinicalTrials.gov on September 11, 2011

2.2 Citeline TrialTrove

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Trial Title
A Randomized, Parallel-Group, Dose-Ranging Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Antiviral Activity of VX-222 and Telaprevir in Combination With and Without Peginterferon-Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C. Quad study.
Disease Type
HCV
Trial Phase
II
Patient Segment
Chronic hepatitis C
Genotype 1
Treatment naive
Sponsorship
Vertex
Primary Drugs
telaprevir
VX-222
Other Drugs
peginterferon alfa-2a (SC)
ribavirin, Roche
Trial Identifier
NCT01080222
Quad study
TrialTroveID-105319
VX09-222-103
ZENITH
Trial Status
Open
Trial Objectives
To study novel combination regimens of telaprevir with ViroChem's HCV non-nucleoside polymerase inhibitors for the treatment of HCV infection. To assess the safety and efficacy of combination treatment with VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and ribavirin. To evaluate safety and antiviral activity, including sustained viral response (SVR) rates using multiple 12-week response-guided regimens of telaprevir/VX-222-based combination therapy, including two-drug regimens that contain only telaprevir and VX-222 in HCV patients.
Primary Endpoints
Primary Endpoint : To assess safety and tolerability of telaprevir/VX-222-based combination therapy. Primary Outcome Measures: Safety and Tolerability [Time Frame: 40 weeks] [Designated as safety issue: Yes]. Assessed by adverse events, physical examinations, vital signs, 12 lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis) vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (clinical chemistry, hematology, and urinalysis).
Other Endpoints
Secondary Endpoint : To assess on-treatment antiviral activity and the proportion of patients in each study arm who achieve SVR. Secondary Outcome Measures: - Proportion of Subjects Who Achieve a Sustained Viral Response [Time Frame: 24 weeks after the completion of the last dose of the assigned study drug treatment regimen] [Designated as safety issue: No]. - Undetectable HCV RNA Measurements [Time Frame: 36 weeks] [Designated as safety issue: No] . - Time to undetectability. - Proportion of subjects who achieve undetectable HCV RNA levels at Week 2, Week 4, Week 8, and Week 12. - Proportion of subjects who achieve undetectable HCV RNA levels at Week 2 and Week 8. - Proportion of subjects who have undetectable HCV RNA levels at the end of treatment. - Proportion of Subjects Who Have a Viral Breakthrough or Relapse [Time Frame: 60 weeks] [Designated as safety issue: No] - Plasma Exposures of VX-222 and Telaprevir [Time Frame: 12 weeks] [Designated as safety issue: No].
Start Date
2010-08-01
Primary Endpoints Reported
2012-06-01
Patient Population
Treatment-Naive subjects with genotype 1 chronic hepatitis C virus infection.
Inclusion Criteria
Ages Eligible for Study: 18 Years to 65 Years Inclusion Criteria: - Males and females of non-childbearing potential. - Genotype 1 chronic hepatitis C. - Laboratory evidence of HCV infection for 6 months. - Histologic evidence of chronic hepatitis C. - Subjects who have a body mass index (BMI) of < or = 35 kg/m^2 (BMI = weight in kg / height^2 in meters). - Treatment Arm E: This arm will enroll only subjects infected with HCV genotype 1b virus. - Treatment Arm F: This arm will enroll only subjects infected with HCV genotype 1a virus.
Exclusion Criteria
Exclusion Criteria: - Subjects who have received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C. - Subjects with any contraindications to peginterferon alfa-2a and/or ribavirin. - Subjects with any other cause of significant liver disease in addition to hepatitis C, which may include, but is not limited to malignancy with hepatic involvement, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis (NASH), or primary biliary cirrhosis. - Histologic evidence of hepatic cirrhosis.
Gender
Both
Age (Min)
18
Age (Min) Units
Years
Age (Max)
65
Age (Max) Units
Years
Prior/Concurrent Therapy
N/A
Target Accrual
150
Reported Sites
21
Identified Sites
9
Actual Accrual
106 as of March 30, 2011
Trial Locations
New Zealand
US
Treatment Plan
This is a phase II study of novel combination regimens of telaprevir with VX-222. The dose of telaprevir will be fixed, and a range of doses of VX-222 will be studied.
Study Keywords
randomized parallel group dose ranging four arm open label dose comparison parallel assignment safety/efficacy interventional proof of concept
Study Design
Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment This is a phase II, parallel group, dose ranging, four arm, proof of concept, tolerability, pharmacokinetic study.
Investigators / Contacts
Medical Monitor, Study Director, Vertex Pharmaceuticals Incorporated Natalie Bzowej, MD, Principal Investigator, California Pacific Medical Center Shelley George, M.D, Responsible Party, Vertex Pharmaceuticals Incorporated Margaret Koziel, M.D, Responsible Party, Vertex Pharmaceuticals Incorporated Younossi, Zobair MD, Principal Investigator, Inova Research Gregory T. Everson, M.D., F.A.C.P., Principal Investigator, Division of Gastroenterology, University of Colorado School of Medicine, Transplant Center & Hepatology Clinic, B154, ROOM 7085, 1635 AURORA CT. B154 P.O. BOX 6510 Cervini, Christine M, Olson, Mary C, Gambarin-Gelwan, Maya, IVarghese, Mathew C, Gross, Rebekah G, Investigators; Weill Cornell Medical College Jacobson, Ira M, Principal Investigator, Weill Cornell Medical College Contact: Central Contact Center Phone: 877-634-VRTX E-mail: medicalinfo@vrtx.com Anna von Bakonyi, California Pacific Medical Center Phone: 415-600-1107 E-mail: vonbaka@sutterhealth.org Heshaam Mir, Inova Research Phone: 703-776-417 E-mail: heshaam.mir@inova.org Adrian M. Di Bisceglie, M.D.,1 Chief of Hepatology, 1St Louis University School of Medicine, St. Louis, MO Email: dibiscam@slu.edu D.R. Nelson2, E. Gane3, K. Alves4, C. De Souza4, T.L. Kieffer4, R.S. Kauffman4, M.S. Sulkowski6, 1St Louis University School of Medicine, St. Louis, MO, 2University of Florida College of Medicine, Gainesville, FL, USA, 3Auckland City Hospital, Auckland, New Zealand, 4Vertex Pharmaceuticals Incorporated, Cambridge, MA, 6Johns Hopkins University, Baltimore, MD, USA. 6Johns Hopkins University, Baltimore, MD, USA. Robert Kauffman, M.D., Ph.D., Senior Vice President, Chief Medical Officer, Vertex.
Trial Results
March 30, 2011 Presented at 46th Annual Meeting of the European Association for the Study of the Liver (EASL) 2011, Berlin, Germany, March 30 - April 3, 2011. Abstract#: 1363 A.M. Di Bisceglie, D.R. Nelson, E. Gane, K. Alves, M.J. Koziel, C. De Souza, T.L. Kieffer, S. George, R.S. Kauffman, I.M. Jacobson, M.S. Sulkowski; VX-222 With TVR Alone or in Combination with Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C: Zenith Study Interim Results. Interim Results: Both DUAL arms were terminated after patients experienced on-treatment viral breakthrough (vBT). No vBT has been observed in either QUAD arm. Median time to undetectable HCV RNA was 4 and 2 weeks in Arms C and D, respectively. The majority of patients in arm D had undetectable HCV RNA by week 2; RVR rates were high in both QUAD arms (Table). Most adverse events (AEs) were mild or moderate; with diarrhea (37%, n = 39), fatigue (36%, n = 38), nausea (34%, n = 36) and rash (23%, n = 24) most frequently observed. One patient (arm B) discontinued due to acute renal failure at week 2. No patient discontinued due to gastrointestinal events. Conclusions: Both DUAL telaprevir/VX-222 arms were stopped due to on-treatment vBT. Conversely, in this interim analysis, no patients in either QUAD arm experienced vBTs. Median time to undetectable HCV RNA in arm D was 2 weeks and the majority (86-87%) of patients had undetectable HCV RNA at week 4. Patients are being followed for SVR and safety. [Tabular data available at source URL.] http://www1.easl.eu/easl2011/program/Posters/Abstract3.htm
Notes
Excerpted from: Vertex Pipeline [Last updated on May 23, 2011] [Accessed on August 11, 2011] VX-222 (Hepatitis C) VX-222 is a small molecule non-nucleoside inhibitor of HCV NS5B polymerase that is being investigated for the treatment of hepatitis C virus infection. http://www.vrtx.com/current-projects/drug-candidates/vx-222.html

July 26, 2011 Press release Interim Data from Phase 2 Study of Combination Regimen Including VX-222 and INCIVEK™ Suggest Potential to Treat Genotype 1 Hepatitis C in as few as 12 Weeks and No More Than 24 Weeks -First data to show potential for viral cure in many patients with a 12-week combination regimen of multiple direct-acting antivirals- CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced interim results from ZENITH, an ongoing Phase 2 study designed to assess the safety, tolerability and efficacy of multiple 12- and 24-week response-guided treatment regimens with VX-222 (400 mg or 100 mg), its lead polymerase inhibitor in development, in combination with INCIVEK™ (telaprevir) tablets, pegylated-interferon and ribavirin in people with genotype 1 chronic hepatitis C who were new to treatment. This is an interim analysis from patients in the four-drug treatment arms and was conducted after these patients completed their assigned treatment. Results showed that 50 percent of people (15/30) in the study who received VX-222 (400 mg) in combination with INCIVEK, pegylated-interferon and ribavirin were eligible to stop all treatment at week 12, and 93 percent (14/15) of these patients had undetectable hepatitis C virus 12 weeks after treatment ended (sustained viral response 12, or SVR12). Patients from the VX-222 (400 mg) treatment arm who were not eligible to stop all treatment at week 12 received an additional 12 weeks of pegylated-interferon and ribavirin alone for 24 total weeks of treatment. The hepatitis C virus was undetectable in 100 percent (13/13) of these patients at the end of 24 weeks. In this study, VX-222, INCIVEK and ribavirin were given twice daily (BID). Interim safety results from the four-drug treatment arms showed that mild gastrointestinal symptoms and mild fatigue were the most frequently reported adverse events. Side effects consistent with the known safety profile of INCIVEK combination treatment also were observed.... ...ZENITH is an ongoing Phase 2 study that initially enrolled 106 people with genotype 1 chronic hepatitis C and began with four treatment arms designed to evaluate multiple response-guided treatment regimens with VX-222, Vertex's lead polymerase inhibitor in development, in combination with INCIVEK, Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin), three medicines approved to treat hepatitis C. In this study, VX-222, INCIVEK and ribavirin were given twice daily. The primary endpoint of the study is safety and tolerability. The secondary endpoint is on-treatment antiviral activity and the proportion of people in each treatment arm who achieve a sustained viral response. Additional results from this study will be submitted for presentation at an upcoming medical meeting. Arms A (n=18) and B (n=29) were designed to evaluate all-oral, two-drug combination regimens of VX-222 (400 mg or 100 mg) and INCIVEK (1,125 mg). Data presented in March at The International Liver Congress™ 2011, the 46th annual meeting of the European Association for the Study of the Liver (EASL), in Berlin, Germany, showed significant initial antiviral activity in people who were treated with VX-222 (400 mg) and INCIVEK. However, these treatment arms were discontinued due to a pre-defined stopping rule related to viral breakthrough. Arms C (n=29) and D (n=30) are ongoing and are designed to evaluate four-drug combination regimens of VX-222 (400 mg or 100 mg), INCIVEK (1,125 mg), pegylated-interferon and ribavirin. Data announced today are from the four-drug treatment arms (Arms C and D). In these two arms, patients were assigned to take all four medicines for the first 12 weeks of treatment. People who had undetectable hepatitis C virus levels in the blood (HCV RNA) at weeks two and eight of treatment were eligible to stop all treatment at week 12. In this study, the amount of hepatitis C virus in the blood was measured by the Roche COBAS® Taqman HCV test (<10 IU/mL undetectable). People who did not meet these criteria were assigned to receive 24 total weeks of treatment: 12 weeks of the four-drug combination regimen followed by 12 weeks of pegylated-interferon and ribavirin alone. This interim analysis includes SVR12 results for the people who were eligible for and completed 12 total weeks of treatment and end-of-treatment results for the people who were assigned to and completed 24 total weeks of treatment. [Tabular data available at source URL.] ...Two additional treatment arms (E and F) were added to the study to evaluate a three-drug, all-oral, interferon-free regimen of VX-222 (400 mg), INCIVEK and ribavirin. Enrollment in these treatment arms is expected to be complete by the end of the third quarter of 2011. Arm E will evaluate people with genotype 1b chronic hepatitis C and Arm F will evaluate people with genotype 1a chronic hepatitis C. Vertex expects to report data from the all-oral treatment arms in the first half of 2012. Interim Safety and Tolerability Results from the Four-drug Treatment Arms The most frequent adverse events observed in the four-drug treatment arms were fatigue, nausea, diarrhea, anemia, pruritis (itchiness) and rash. The majority of events were mild or moderate. Mild diarrhea occurred more frequently in the VX-222 (400 mg) treatment arm. The majority of people in the study did not use medication to control diarrhea. There were no treatment discontinuations due to diarrhea. Six patients discontinued treatment due to adverse events; three each from the 400 mg and 100 mg treatment arms. Two people from each arm discontinued treatment before week 12 and one person in each arm discontinued treatment between weeks 12 and 24 while they were receiving pegylated-interferon and ribavirin alone. http://investors.vrtx.com/releasedetail.cfm?ReleaseID=593939

Locations/Contacts Study Sites and Contact information (Last Updated on July 11, 2011) [Last accessed on August 11, 2011] Contact: Central Contact Center 877-634-VRTX medicalinfo@vrtx.com United States, California Recruiting La Jolla, California, United States Active, not recruiting San Francisco, California, United States United States, Colorado Recruiting Aurora, Colorado, United States United States, Florida Active, not recruiting Gainesville, Florida, United States United States, Georgia Recruiting Atlanta, Georgia, United States Recruiting Marietta, Georgia, United States United States, Maryland Recruiting Lutherville, Maryland, United States United States, Minnesota Not yet recruiting Rochester, Minnesota, United States United States, Missouri Recruiting St. Louis, Missouri, United States United States, New Jersey Active, not recruiting Egg Harbor Township, New Jersey, United States United States, New York Recruiting New York, New York, United States United States, North Carolina Not yet recruiting Chapel Hill, North Carolina, United States Recruiting Durham, North Carolina, United States United States, Ohio Recruiting Cincinnati, Ohio, United States United States, Rhode Island Recruiting Providence, Rhode Island, United States United States, Tennessee Recruiting Germantown, Tennessee, United States United States, Texas Recruiting Arlington, Texas, United States Recruiting San Antonio, Texas, United States United States, Virginia Active, not recruiting Falls Church, Virginia, United States New Zealand Recruiting Auckland, New Zealand Active, not recruiting Christchurch, New Zealand http://www.clinicaltrials.gov/ct2/show/study/NCT01080222

June 23, 2011 Excerpted from: HCV Resistance Workshop - Boston, Massachusetts Slide#: 34 Telaprevir (PI) + VX-222 (non-nuc): ZENITH ZENITH: Phase II study of telaprevir (T) plus VX-222, with or without Peg-IFN/RBV for 12 weeks in treatment-naive HCV genotype 1 patients [Tabular data available at the source URL] Slide#: 35 No virologic breakthrough in quad-therapy arms. Virologic breakthrough common in VX-222/TVR dual-therapy arms (17% to 31%) Both dual regimens stopped early per protocol. [Graphical data available at the source URL] http://regist2.virology-education.com/2011/6HEPC/docs/JS_02_Jacobson.pdf

June 1, 2011 Sanford C. Bernstein & Co. Strategic Decisions Conference During the conference, Vertex stated that it expects to have data on the 'quad' study in Q3 2011. [No URL available]

May 16, 2011 Excerpted from: Inova Research Studies: Active/Enrolling Page#: 42 of 60 Principal Investigator: Younossi, Zobair MD Study Title: VX09-222-103: A Randomized, Parallel Group, Dose-Ranging Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Antiviral Activity of VX 222 and Teleprevir in Combination with and without Perinterferon-Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects with Genotype 1 Chronic Hepatitis C Contact: Heshaam Mir, 703-776-4171, heshaam.mir@inova.org http://www.inova.org/upload/docs/Education%20&%20Research/Open-Active%20Research%20Studies%20May%202011.pdf

Excerpted from: CPMC Liver Transplant/Hepatology/Hepatitis/Liver Failure Clinical Trials Hepatitis B Principal Investigator/Contact Information: Natalie Bzowej, MD Anna von Bakonyi 415-600-1107 Email: vonbaka@sutterhealth.org Protocol Title: A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection. Patient Population: Subjects with genotype 1 chronic hepatitis C who have never received treatment. Recruitment Period: Active/ Closed to Enrollment. http://www.cpmc.org/professionals/research/trials/heplisting.html

Study Timing Study Start Date: August 2010 Estimated Study Completion Date: March 2013 Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure) http://www.clinicaltrials.gov/ct2/show/NCT01080222

May 03, 2011 Excerpted from: Vertex Reports First Quarter 2011 Financial Results and Reviews Milestones for Key Development Programs - Hepatitis C: FDA decision on NDA for INCIVEK (telaprevir) expected this month CAMBRIDGE, Mass.--(BUSINESS WIRE)- Vertex Pharmaceuticals Incorporated...today provided an update on recent progress in its key development programs, discussed upcoming milestones and reported consolidated financial results for the quarter ended March 31, 2011... ...Recent Clinical Development Progress Hepatitis C: ...Phase 2 Combination Study of INCIVEK (telaprevir) and VX-222 - Vertex is conducting a Phase 2 clinical trial evaluating multiple 12- and 24-week response-guided regimens of INCIVEK (telaprevir) dosed in combination with Vertex's lead investigational polymerase inhibitor, VX-222, for the treatment of hepatitis C. The study currently includes three treatment arms. Two of the treatment arms are fully enrolled and are evaluating four-drug combinations of INCIVEK (telaprevir; 1,125 mg; BID), VX-222 (400 mg or 100 mg; BID), pegylated-interferon and ribavirin. Vertex expects to complete enrollment in the second quarter of 2011 in a three-drug treatment arm that will evaluate an all-oral, interferon-free regimen of INCIVEK (telaprevir; 1,125 mg), VX-222 (400 mg) and ribavirin dosed twice daily. A final arm may be added to the trial per protocol based on data from other arms of the study. In April, Vertex announced interim results from this study and expects to present additional data from the study in the second half of 2011... http://investors.vrtx.com/releasedetail.cfm?ReleaseID=574129

April 28, 2011 Excerpted from: Antiviral Drugs Advisory Committee - April 28, 2011 - Briefing Document Page#: 135 Table 47 Proposed and On-Going Studies with Telaprevir Study Number: VX09-222-103 Purpose of study: Safety and tolerability of combination treatment with VX-222 and telaprevir administered for 12 weeks with and without Peg-IFN/RBV http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562.pdf

March 31, 2011 Interim Phase 2 Data Showed Rapid Viral Response to VX-222 in Combination with Telaprevir, Pegylated-Interferon and Ribavirin Among People With Hepatitis C BERLIN--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated today announced interim results from an ongoing Phase 2 study (ZENITH) designed to assess the safety and tolerability of 12-week response-guided treatment regimens with its polymerase inhibitor, VX-222, and its protease inhibitor, telaprevir, in combination with pegylated-interferon and ribavirin in people with genotype 1 chronic hepatitis C who were new to treatment. The study enrolled 106 people into one of four treatment groups. Among those who received VX-222 (400 mg) in combination with telaprevir, pegylated-interferon and ribavirin, interim data showed that 90 percent (27/30) of them had undetectable hepatitis C virus at week 12. Half (15/30) of those in the VX-222 (400 mg) treatment group were eligible to stop all treatment at week 12. People in this same treatment group who were not eligible to stop all treatment at 12 weeks were assigned to receive 24 total weeks of treatment: 12 weeks of the four-drug regimen followed by 12 weeks of pegylated-interferon and ribavirin alone. Preliminary safety results showed that the most frequently reported adverse events were mild gastrointestinal symptoms and mild fatigue. At the time of this analysis, there were no discontinuations due to gastrointestinal symptoms. Data from this study are being presented today at The International Liver Congress 2011, the 46th annual meeting of the European Association for the Study of the Liver (EASL) in Berlin, Germany. "Telaprevir triple therapy demonstrated significant improvements in viral cure rates and an ability to halve treatment time to 24 weeks for many people in late-stage studies," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex... ...Using an intent-to-treat analysis, 57 percent (17/30) of people treated with VX-222 (400 mg) in combination with telaprevir, pegylated-interferon and ribavirin had undetectable hepatitis C virus by week two. Among people who were treated with VX-222 (100 mg) in combination with telaprevir, pegylated-interferon and ribavirin, 38 percent (11/29) had undetectable hepatitis C virus by week two. To determine if patients were eligible to stop all treatment at 12 weeks in ZENITH, they had to have undetectable hepatitis C virus at weeks two and eight. Using the eligibility criteria for a 12-week total treatment duration, half (15/30) of the patients in the high-dose VX-222 combination group and 38 percent (11/29) in the low-dose combination group were eligible to stop all treatment at 12 weeks. Ninety percent (27/30) of patients in the high-dose VX-222 group had undetectable hepatitis C virus by week 12 as did 83 percent (24/29) in the low-dose VX-222 group. No viral breakthrough was observed through week 12 among patients receiving the four-drug combinations. "The early data from this study are encouraging because they showed patients had a very rapid decline in hepatitis C virus as early as the second week of treatment," said Adrian Di Bisceglie, M.D., Chief of Hepatology at Saint Louis University School of Medicine... ...ZENITH is an ongoing Phase 2 study that enrolled 106 people and began with four treatment arms evaluating two-drug and four-drug combination regimens. The primary endpoint is safety and tolerability and the secondary endpoint is on-treatment antiviral activity and the proportion of people in each treatment arm who achieve a sustained viral response (SVR, defined as undetectable hepatitis C virus 24 weeks after the end of treatment). The study is designed to evaluate various combinations of VX-222, telaprevir, pegylated-interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C. In this study, VX-222, telaprevir and ribavirin are given twice daily. Arms A (n=18) and B (n=29) were designed to evaluate the all-oral, two-drug combination regimens of VX-222 (400 mg or 100 mg) and telaprevir (1,125 mg). Both of these study arms were discontinued due to a pre-defined stopping rule related to viral breakthrough. Arms C (n=29) and D (n=30) are ongoing and designed to evaluate the four-drug combination regimens of VX-222 (400 mg and 100 mg), telaprevir (1,125 mg), pegylated-interferon and ribavirin. An additional treatment arm has been added to the study to evaluate an all-oral, three-drug regimen of VX-222, telaprevir and ribavirin in people with genotype 1b chronic hepatitis C. This study arm is now open for enrollment. A sixth and final arm may be added to the trial per protocol based on data from the study... ...Preliminary Safety and Tolerability The 12-week safety and tolerability results are preliminary and include data on all patients enrolled in the study: those enrolled in the two-drug (n=47) and four-drug (n=59) treatment arms. The most frequent adverse events observed in this study were mild gastrointestinal symptoms (including diarrhea, nausea and vomiting) and mild fatigue. No patients discontinued due to gastrointestinal symptoms. Preliminary safety data indicate that there were six discontinuations due to adverse events among the four treatment arms through week 12. There were two serious adverse events considered by the investigator to be potentially related to study medication: acute renal failure (Arm B), which resolved after study medications were discontinued and anemia (Arm C). There was one additional severe adverse event reported of pneumonia, septic shock and renal failure; this severe adverse event was considered by the investigator to be unrelated to study medication. The three additional discontinuations included rash (n=2) and a motor vehicle accident with facial fractures (n=1)... [Tabular data available at the source URL] http://investors.vrtx.com/releasedetail.cfm?ReleaseID=560946

March 07, 2011 New Data on Telaprevir and VX-222 for the Treatment of Hepatitis C Accepted For Presentation at EASL Annual Meeting - First presentation of data from ongoing Phase 2 study evaluating response-guided, 12- and 24-week regimens of telaprevir and VX-222 combined with pegylated-interferon and ribavirin CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated announced today that 15 abstracts on the company's medicines in development for hepatitis C, including its protease inhibitor, telaprevir, and polymerase inhibitor, VX-222, were accepted for presentation at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) in Berlin, Germany, March 30 to April 3, 2011. Highlights of data presentations include: ...- The first data from an ongoing Phase 2 study evaluating 12- and 24-week response-guided regimens of telaprevir and VX-222 in combination with pegylated-interferon and ribavirin will be presented during a late-breaker session (Abstract #1363)... ...The titles of the abstracts related to Vertex's medicines in development for hepatitis C are included below and the complete abstracts are now available through the EASL website... ...Poster Presentations - Late Breaker #1363: "VX-222 with TVR Alone or in Combination with Peginterferon ALFA-2A and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C: ZENITH Study Interim Results"; March 31 - April 2, 2011... http://investors.vrtx.com/releasedetail.cfm?ReleaseID=554900

February 04, 2011 Excerpted from: Vertex Reports 2010 Financial Results and Highlights Recent Progress in Hepatitis C and Cystic Fibrosis Development Programs ...CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated...today provided an update on recent progress in its late-stage development programs in hepatitis C virus (HCV) infection and cystic fibrosis (CF) and reported consolidated financial results for the year ended December 31, 2010... ...Recent Clinical Development Progress ...Vertex today provided the following additional updates, reflecting recent progress in its development programs: ...- Continued Progress in Phase 2 Study of Telaprevir and VX-222 - Vertex is conducting a Phase 2 clinical trial evaluating multiple 12-week and 24-week, response-guided regimens of telaprevir, Vertex's lead medicine in development for hepatitis C, dosed in combination with its hepatitis C virus polymerase inhibitor VX-222. The study currently includes three treatment arms. Two of the treatment arms are fully enrolled and are evaluating four-drug combinations of telaprevir (1,125 mg; BID), VX-222 (400 mg or 100 mg; BID), Pegasys (pegylated-interferon alfa-2a) and Copegus (ribavirin). All of the people in the four-drug treatment arms will have reached the 12-week timepoint in the study by the end of February. - On-treatment data from the study are expected in the first quarter of 2011 from both of the four-drug treatment arms. - In addition, enrollment is expected to begin in the first quarter of 2011 for a three-drug treatment arm of this study designed to evaluate the potential of an all-oral, interferon-free regimen of telaprevir (1,125 mg), VX-222 (400 mg) and ribavirin dosed twice daily... http://investors.vrtx.com/releasedetail.cfm?ReleaseID=547637

December 21, 2010 Press release Vertex Provides Update to Ongoing Phase 2 Study Evaluating Combinations of Telaprevir and VX-222 for the Treatment of Hepatitis C -Two-drug treatment arm of telaprevir and VX-222 alone discontinued -Study continues with three arms, including all-oral combination of Vertex's lead protease and polymerase inhibitors with ribavirin- -Both of the four-drug treatment arms are fully enrolled; the majority of patients in these arms have reached 8 weeks or more of treatment- CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced a modification of its Phase 2 clinical trial evaluating 12-week, response-guided regimens of its lead investigational hepatitis C virus (HCV) protease inhibitor, telaprevir, in combination with its lead investigational HCV polymerase inhibitor, VX-222. The company has discontinued the second two-drug treatment arm of telaprevir and VX-222 alone as a result of meeting a pre-defined stopping rule related to viral breakthrough. This two-drug arm was designed to evaluate a 12-week combination regimen of VX-222 (400 mg) and telaprevir (1,125 mg) dosed twice daily without pegylated-interferon and ribavirin. The first two-drug arm was discontinued in October 2010 and was designed to evaluate a 12-week combination regimen of VX-222 (100 mg) and telaprevir (1,125 mg). The study will continue as planned with three treatment arms. Two of the treatment arms are fully enrolled and are evaluating four-drug combinations of telaprevir (1,125 mg), VX-222 (400 mg or 100 mg), Pegasys (pegylated-interferon alfa-2a) and Copegus (ribavirin). The last patient was randomized and began treatment with a four-drug regimen in November 2010. There are patients in the four-drug treatment arms who have recently started treatment and have not yet reached week 8 of therapy. More than half of patients in the treatment arms have received eight weeks or more of treatment and approximately one third of patients are in weeks 10 through 12 of treatment. Some patients in this study have completed therapy. Interim data from both of the four-drug treatment arms are expected in the first quarter of 2011. In November 2010, Vertex announced the planned addition of a new three-drug treatment arm designed to evaluate the potential of an all-oral, interferon-free regimen of telaprevir (1,125 mg), VX-222 (400 mg) and ribavirin dosed twice daily. Enrollment in this new treatment arm is expected to begin in the first quarter of 2011. "This trial has provided important information regarding telaprevir and VX-222-based combination regimens, and three of the five treatment arms are proceeding as planned," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex. "We are pleased with the progress of both four-drug treatment arms and look forward to the first quarter of 2011 when on-treatment data from these arms will become available and enrollment in the three-drug treatment arm is expected to begin." About the Ongoing Phase 2 Trial of Telaprevir and VX-222 In August 2010, patients enrolled in this randomized, parallel-group, dose-ranging Phase 2 trial started receiving treatment. The primary endpoint of this trial is to assess safety and tolerability of 12-week, telaprevir/VX-222-based combination therapy in people with genotype 1 chronic hepatitis C. A secondary endpoint of this study is to assess on-treatment antiviral activity and the proportion of patients in each study arm who achieve a sustained viral response (SVR; defined as undetectable HCV RNA 24 weeks after the end of treatment). Patients who meet the response-guided criteria during treatment (undetectable HCV RNA at week 2 and week 8 of treatment) stop all therapy at week 12. The planned addition of the three-drug treatment arm to the study took into account an initial review of adverse events among people treated with telaprevir/VX-222 combination regimens in this study. Enrollment in this new study arm is expected to begin in the first quarter of 2011 pending completion of institutional review board (IRB) approvals and consultations with regulatory agencies. A sixth and final arm may be added to the trial per protocol based on data from the study expected in the first quarter of 2011. http://investors.vrtx.com/releasedetail.cfm?ReleaseID=538347

November 30, 2010 The 22nd Annual Piper Jaffray Healthcare Conference Vertex presentation ...So we're hopeful about quad therapy being very successful, subject to safety. Because it's four drugs now and can a patient tolerate four drugs for 12 weeks? The interesting thing about this study is it started in August. They completed enrollment in October. And here we are, heading into December, and before we know it, we'll be in the new year. No news is good news on this study. So I'll leave you with that thought -- no news is good news on this study. Because if we run into a safety event where we have to discontinue an arm, we'd have to disclose that. If we run into viral breakthrough, as we did with one of the low-dose arms in this study, we'd have to discontinue that arm and disclose that. So you have to understand that the passage of time of a very short study that's only 12 weeks and no news is suggesting it's going as planned. Now, we have to wait for that data, and that data will be out in the first quarter of 2011. But if we had the chance of creating a quad therapy at a minimum -- a quad therapy for 12 weeks with high viral cure, that's another advance to therapy. And that's how we're thinking about that -- that combination study. [No URL available]

November 10, 2010 Vertex Announces Plans to Enroll Additional Treatment Arm in Ongoing Phase 2 Combination Study of Telaprevir and VX-222 for the Treatment of People with Hepatitis C - New treatment arm to evaluate all oral, triple combination regimen of telaprevir, VX-222, and ribavirin CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced plans to enroll an additional treatment arm as part of its ongoing Phase 2 clinical trial evaluating 12-week regimens of Vertex's lead investigational hepatitis C virus (HCV) protease inhibitor, telaprevir, in combination with its lead investigational HCV polymerase inhibitor, VX-222. The planned treatment arm is supported by emerging data from multiple ongoing clinical trials of direct-acting antiviral (DAA) therapies, including the trial of telaprevir/VX-222-based combination therapy, which suggest that adding ribavirin to a DAA treatment regimen may increase antiviral activity. In the additional arm, Vertex plans to evaluate a 12-week combination of three oral therapies - VX-222, telaprevir and ribavirin - dosed twice a day within a response-guided regimen... ...About the Ongoing Phase 2 Trial of Telaprevir and VX-222 Beginning in August 2010, patients enrolled in the randomized, parallel-group, dose-ranging Phase 2 trial started receiving treatment. The primary endpoint of this trial is to assess safety and tolerability of 12-week telaprevir/VX-222-based combination therapy in people with genotype 1 chronic hepatitis C. A secondary endpoint of this study is to assess on-treatment antiviral activity and the proportion of patients in each study arm who achieve a sustained viral response (SVR; defined as undetectable HCV RNA 24 weeks after the end of treatment). If patients meet response-guided criteria during treatment (undetectable HCV RNA at week 2 and week 8 of treatment), they may be eligible to stop all therapy at 12 weeks. The study includes treatment arms that are evaluating 12-week, response-guided regimens of two- and four-drug telaprevir/VX-222 combination therapy, given twice daily, with and without Pegasys (pegylated-interferon alfa-2a) and Copegus (ribavirin). Trial sites for the two- and four-drug ongoing arms completed enrollment in October 2010. The additional three-drug treatment arm of telaprevir, VX-222 and ribavirin announced today is expected to begin patient enrollment in the first quarter of 2011, pending completion of institutional review board (IRB) approvals and consultation with regulatory agencies. Based on further results from the ongoing treatment arms, Vertex may add an additional arm in this study... http://investors.vrtx.com/releasedetail.cfm?ReleaseID=528935

Excerpted from: VX-222 (HCV Infection): Last Revised 02/22/11 [Last Accessed on: May 9, 2011] ...Vertex is currently conducting the first clinical trial of telaprevir dosed in combination with VX-222. This Phase 2 proof-of-concept trial is designed to evaluate safety and sustained viral response (SVR) rates using 12-week response-guided regimens of telaprevir/VX-222-based combination therapy in people with genotype 1 hepatitis C. The trial is evaluating treatment regimens that include four-drug regimens of telaprevir, VX-222, pegylated-interferon and ribavirin, as well as a two-drug regimen of only telaprevir and VX-222, both dosed twice daily. Vertex expects to obtain on-treatment clinical data from this trial in the first half of 2011 and SVR data in the second half of 2011. [Content of the URL has changed] http://www.vrtx.com/current-projects/drug-candidates/vx-222.html

September 28, 2010 JMP Securities LLC - Healthcare Focus Conference Vertex Pharmaceuticals Presentation Ian Smith - Vertex Pharmaceuticals Incorporated - EVP & CFO ...As far as understanding how we progress with the study...we're committed to data that's meaningful and providing that externally. Now what is meaningful? At least probably seeing on treatment viral kinetics and safety of at least four weeks of duration from the patients within the study....The timing of that could be towards the end of this year pending enrollment or it could be early 2011 pending enrollment. [No URL available.]

June 24, 2010 Wells Fargo Securities Healthcare Conference Vertex Pharmaceuticals Presentation During the presentation Vertex stated that it expects to have data readouts for the telaprevir -VX222 combination study in the second half of the year. [No URL available]
Supporting URLs
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=368695
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=377786
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=401544
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=418761
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=436550
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=443116
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=447807
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=460352
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=462138
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=493622
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=522615
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=528935
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=538347
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=547637
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=554900
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=560946
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=574129
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=593939
http://investors.vrtx.com/secfiling.cfm?filingID=1047469-09-5373
http://regist2.virology-education.com/2011/6HEPC/docs/JS_02_Jacobson.pdf
http://vivo.med.cornell.edu/display/grant-004570-001
http://www.clinicaltrials.gov/ct2/show/NCT01080222
http://www.cpmc.org/professionals/research/trials/heplisting.html
http://www.cusomgateway.com/uploaded-provider-files/2241/Everson%20CV2.doc
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562.pdf
http://www.hopkinsmedicine.org/Medicine/viralhep/research/clintrials.html
http://www.inova.org/upload/docs/Education%20&%20Research/Open-Active%20Research%20Studies%20May%202011.pdf
http://www.medicine.ufl.edu/gastro/gastro_liverUnitClinicalTrials.asp
http://www.sec.gov/Archives/edgar/data/875320/000104746909005373/a2192154z10-q.htm
http://www.sec.gov/Archives/edgar/data/875320/000104746909007495/a2194024z10-q.htm
http://www.sec.gov/Archives/edgar/data/875320/000104746910004633/a2198073z10-q.htm
http://www.sec.gov/Archives/edgar/data/875320/000104746910006916/a2199547z10-q.htm
http://www.sec.gov/Archives/edgar/data/875320/000104746910008963/a2200597z10-q.htm
http://www.vrtx.com/current-projects/drug-candidates/pipeline.html
http://www.vrtx.com/current-projects/drug-candidates/vx-222.html
http://www1.easl.eu/easl2011/program/Posters/Abstract3.htm
Last Modified
2011-08-11
Last Full Review
2011-08-11
Internal Comments
N/A
Record URL
http://jnj.citeline.com/xt_view.asp?trialid=105319&target=10
Record Number
105319
Drug Name(s)
telaprevir
VX-222
peginterferon alfa-2a (SC)
ribavirin, Roche

© 2002-2011 Citeline Inc. All rights reserved. This information is subject to a TrialTrove license agreement. See www.citeline.com/subscriptionlicense.html.

2.3 Adis Clinical Trials Database

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A Randomized, Parallel-Group, Dose-Ranging Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Antiviral Activity of VX-222 and Telaprevir in Combination With and Without Peginterferon-Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C.
700053358


Study Details
Purpose
This dose-ranging trial aims to evaluate the efficacy, pharmacokinetics and tolerability of telaprevir + VX 222 [Vertex Pharmaceuticals], alone or combined with peginterferon alfa-2a + ribavirin, in treatment-naive patients with genotype 1 hepatitis C. The primary endpoint is the tolerability of the combination therapy.
Start Date: 01 Mar 2010 (actual)
End Date: 01 Mar 2013 (planned)

Details Study Design: multicentre, open, parallel, randomised
Study Controls: drug combination comparison; drug dosage comparison; drug regimen comparison
Study Status: Recruiting
Study Phase: II
Study Location: Multinational New Zealand USA
Study Endpoint: Drug concentration, Sustained virological response, Viral load, Virological relapse rate

Subjects Type: patients
Number: 150
Age: 18-65 years, adult

Patient Inclusion: Males and females of non-childbearing potential - Genotype 1 chronic hepatitis C - Laboratory evidence of HCV infection for 6 months - Histologic evidence of chronic hepatitis C - Subjects who have a body mass index (BMI) of <=35 kg/m2 (BMI = weight in kg / height2 in meters) - Treatment Arm E: This arm will enroll only subjects infected with HCV genotype 1b virus - Treatment Arm F: This arm will enroll only subjects infected with HCV genotype 1a virus.
Patient Exclusion: Subjects who have received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C - Subjects with any contraindications to peginterferon alfa-2a and/or ribavirin - Subjects with any other cause of significant liver disease in addition to hepatitis C, which may include, but is not limited to malignancy with hepatic involvement, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis (NASH), or primary biliary cirrhosis - Histologic evidence of hepatic cirrhosis.

Ongoing Trial Comments
The trial will utilise response-guided criteria aimed at evaluating shorter-duration treatment regimens. All patients, regardless of treatment group, whose hepatitis C virus RNA levels are undetectable (less than 10 IU/mL) at week 2 and week 8 of treatment, will stop their assigned treatment at week 12. Patients who do not meet these criteria will complete their assigned treatment and at week 12, those in the 2-drug regimens will receive follow-on therapy of 24 weeks of peginterferon and ribavirin, for a total of 36 weeks of treatment. Patients in the 4-drug regimens (arms C and D) who do not meet these criteria at week 12 will receive an additional 12 weeks of follow-on therapy with peginterferon and ribavirin for a total of 24 weeks.

Two additional treatment arms were added to the trial in early 2011 (arms E and F). These arms will evaluate an oral, interferon-free three-drug regimen. Arm E will include patients with genotype 1b chronic hepatitis C and Arm F will include patients with genotype 1a chronic hepatitis C.

According to the ClinicalTrials.gov record, the estimated completion date is March 2013 and the final data collection date for the primary outcome measure is April 2011.

Study Centre Details
NameCountryInvestigatorsContact Details
ArlingtonUSA 
AtlantaUSA 
AucklandNew Zealand 
AuroraUSA 
Chapel HillUSA 
ChristchurchNew Zealand 
CincinnatiUSA 
DurhamUSA 
Egg Harbor TownshipUSA 
Falls ChurchUSA 
GainesvilleUSA 
GermantownUSA 
La JollaUSA 
LuthervilleUSA 
MariettaUSA 
New YorkUSA 
ProvidenceUSA 
RochesterUSA 
San AntonioUSA 
San FranciscoUSA 
St LouisUSA 
Vertex Pharmaceuticals, CambridgeUSAKoziel M877-634-VRTXE-mail: medicalinfo@vrtx.com

Study Status History
DateEventCommentUpdate Date
29/07/2011Other trial eventProfile reviewed.29/07/2011
26/07/2011Interim resultsInterim results from the four-drug treatment arms were reported in a Vertex media release. Additional data will be presented at a future conference.29/07/2011
26/07/2011Other trial eventA second three-drug (interferon-free) treatment arm has been added, and enrolment in both three-drug arms is expected to be completed by the end of the third quarter of 2011.29/07/2011
12/07/2011Other trial eventLast checked against ClinicalTrials.gov record.16/07/2011
04/05/2011Other trial eventAdditional data are expected in the second half of 2011.17/05/2011
04/05/2011Other trial eventThe two 4-drug combination arms are fully enrolled and the third 3-drug combination arm is expected to complete enrolment in the second quarter of 2011, according to a Vertex Pharmaceuticals media release.17/05/2011
04/05/2011Status change - recruitingStatus changed from active, no longer recruiting to recruiting.29/07/2011
03/04/2011Interim resultsInterim results presented at the 46th Annual Meeting of the European Association for the Study of the Liver.06/04/2011
07/03/2011Other trial eventInterim results will be presented at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) in March 2011, according to a Vertex Pharmaceuticals (abstract 1363).08/03/2011
07/03/2011Other trial eventTrial acronym ZENITH added, as reported in a Vertex Pharmaceuticals media release.08/03/2011
03/02/2011Other trial eventAccording to a media release from Vertex: All of the people in the four-drug treatment arms will have reached the 12-week timepoint in the study by the end of February.07/02/2011
03/02/2011Other trial eventEnrollment is expected to begin in the first quarter of 2011 for a three-drug treatment arm of this study designed to evaluate the potential of an all-oral, interferon-free regimen of telaprevir VX-222 and ribavirin dosed twice daily.07/02/2011
03/02/2011Other trial eventOn-treatement data are expected within the first quarter of 2011 for each of the four-treatment arms of the study, according to Vertex.07/02/2011
21/12/2010Other trial eventThe second 2-drug treatment arm has been discontinued as a result of meeting a predefined stopping rule related to viral breakthrough, according to a Vertex Pharmaceuticals media release.22/12/2010
21/12/2010Other trial eventTwo of the treatment arms are fully enrolled, with the last patient in a 4-drug regimen enrolled in November 2010, according to a Vertex Pharmaceuticals media release. Interim data from the 4-drug treatment arms is expected in quarter 1 2011.22/12/2010
10/11/2010Protocol amendmentVertex Pharmaceuticals announced that an additional treatment arm comprising a triple combination regimen of telaprevir, VX 222 and ribavirin is expected to begin patient enrolment in the first quarter of 2011.19/11/2010
26/10/2010Status change - active, no longer recruitingStatus changed from recruiting to active, no longer recruiting, according to a Vertex media release.26/10/2010
26/10/2010Protocol amendmentArm A discontinued, according to a Vertex media release.26/10/2010
16/04/2010Other trial eventTarget accrual is expected to be reached in quarter 2 of 2010.19/04/2010
06/03/2010Other trial eventPlanned number of patients changed from 100 to 150 and official title added as reported by ClinicalTrials.gov.09/03/2010
06/03/2010Other trial eventNew source identified and integrated (ClinicalTrials.gov: US National Institutes of Health, NCT01080222).09/03/2010
06/03/2010Completion datePlanned end date (1 Mar 2013) added as reported by ClinicalTrials.gov.09/03/2010
01/03/2010Other trial eventInterim results are expected to be obtained in the second half of 2010, according to a Vertex media release.03/03/2010
01/03/2010Status change - recruitingThis trial has been initiated according to a information published in a Vertex media release.03/03/2010
08/02/2010New trial recordNew trial record08/02/2010

Disease Treated
IndicationPatient Segment
Hepatitis-Cchronic
Hepatitis-Cgenotype 1
Hepatitis-Ctreatment-naive
Various-toxicities 

Treatments
NameDoseRouteFreqDur.
Peginterferon alfa-2a180 µg/doseSC inj1/week12 or 24 weeks
Peginterferon alfa-2a180 µg/doseSC inj1/week12 weeks
Ribavirin1000 or 1200 mg/dayPObid12 or 24 weeks
Ribavirin1000 or 1200 mg/dayPObid12 weeks
Telaprevir2250 mg/dayPObid12 weeks
VX 222200 mg/dayPObid12 weeks
VX 222800 mg/dayPObid12 weeks


Copyright Adis International

3.1 ClinicalTrials.Gov

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Trial Identifier
CR013711
OPTIMIZE-HCV
VX-950-C211
NCT01241760
Trial Title
VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naive Patients With Genotype 1 Chronic Hepatitis C Virus Infection.
Original Title
A Randomized, Open-label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-naive Subjects With Genotype 1 Chronic Hepatitis C Virus Infection.
Sponsor(s)
Tibotec BVBA
Vertex Pharmaceuticals Incorporated
Source
Tibotec BVBA
Oversight
United States: Food and Drug Administration
USA: FOOD AND DRUG ADMINISTRATION - CENTER FOR DRUG EVALUATION AND RESEARCH
Brief Summary
The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naÃ-ve patients with chronic HCV genotype 1 infection.
Detailed Description
This is a randomised (study drug assigned by chance), open-label (all persons know the study drug assignment) multicenter study to evaluate the effectiveness of telaprevir administered orally as 1125 milligram (mg) twice daily versus 750mg every 8 hours in combination with Peg-IFN-alfa-2a, administered via intramuscular injection once a week, and ribavirin, administered as an oral tablet twice a day, in treatment-naïve patients with chronic HCV genotype 1 infection. Telaprevir will be given orally (by mouth) from Day 1 through Week 12 as 3 tablets (1125mg) twice daily or 2 tablets (750mg) every 8 hours. Peg-IFN-alfa-2a will be administered once a week as an injection under the skin (180 microgram/week) from Day 1 through Week 24 or 48 (based on the patient's treatment response on week 4). Ribavirin is administered orally (by mouth) twice daily from Day 1 through Week 24 or 48 (based on the patient's treatment response on week 4) as 1,000-1,200mg per day.
Overall Status
Active, not recruiting
Start Date
December 2010
Completion Date
October 2012 (Anticipated)
Phase
Phase 3
Study Type
Interventional
Study Design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
# Arms
4
Enrollment
742 (Actual)
Eligibility Criteria
Inclusion Criteria:

- Patient has chronic HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL

- Patients should not have had any previous treatment for hepatitis C

- Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period

- Patients with cirrhosis should have serum alpha-fetoprotein (AFP) <= 50 ng/mL. If AFP > 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period

- A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV.

Exclusion Criteria:

- Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype

- Patient has a pre-existing psychiatric condition

- Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C

- Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection

- Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).
Gender
Both
Minimum Age
18 Years
Maximum Age
70 Years
Healthy Volunteers?
No
Last Changed Date
2011-07-21
Interventions
NameTypeDescriptionGroup
Pegylated interferon alfa-2aDrug180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks003
RibavirinDrugdepending on the patient's treatment response at week 4004
TelaprevirDrug1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks002
TelaprevirDrug750 mg (2 oral tablets) every 8 hours for 12 weeks001
Drugs
Pegylated interferon alfa-2a
Ribavirin
Telaprevir
Primary Outcome
Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels.
Secondary Outcome
The safety and tolerability of the 2 dose regimens of telaprevir.
The effect of IL28B genotype on viral response.
The pharmacokinetics of telaprevir, Peg-IFN-alpha-2a, and ribavirin and pharmacokinetic-pharmacodynamic relationships for safety and efficacy.
The changes from baseline in the amino acid sequence of the HCV NS3-4A region.
Condition
Genotype 1 Chronic Hepatitis C
Treatment Naive
Overall Official
Tibotec Pharmaceuticals Clinical Trial
Study Director
Tibotec Pharmaceutical Limited
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Num. Locations
0
Num. Recruiting
0

Information obtained from ClinicalTrials.gov on September 11, 2011

3.2 Citeline TrialTrove

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Trial Title
A Randomized, Open-label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-naive Subjects With Genotype 1 Chronic Hepatitis C Virus Infection.
Disease Type
HCV
Trial Phase
III
Patient Segment
Chronic hepatitis C
Genotype 1
Treatment naive
Sponsorship
Johnson & Johnson/Janssen Biotech/Tibotec {J&J/Centocor Ortho Biotech/Tibotec Therapeutics {J&J/Ortho Biotech/Tibotec}}
Vertex
Primary Drugs
telaprevir
Other Drugs
peginterferon alfa-2a (SC)
ribavirin, Roche
Trial Identifier
CR013711
EudraCT: 2010-021628-84
NCT01241760
OPTIMIZE
OPTIMIZE-HCV
TrialTroveID-126829
VX-950-C211
Trial Status
Closed
Trial Objectives
To evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naive patients with chronic HCV genotype 1 infection. To evaluate the effectiveness of telaprevir administered orally as 1125 milligram (mg) twice daily versus 750mg every 8 hours in combination with Peg-IFN-alfa-2a, administered via intramuscular injection once a week, and ribavirin, administered as an oral tablet twice a day, in treatment-naive patients with chronic HCV genotype 1 infection.
Primary Endpoints
Primary objective: To demonstrate non-inferiority of BID telaprevir versus telaprevir dosed every eight hours as measured by SVR. Primary endpoint: Sustained viral response (SVR) 24 weeks after the end of all treatment. Primary Outcome Measures: Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels. [ Time Frame: 24 weeks after the last planned dose of study drugs. ] [ Designated as safety issue: No ]. - To demonstrate the non-inferiority in sustained viral response (SVR24palnned) of telaprevir administered as 1125 mg twice daily (bid) versus 750 mg every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in treatment-naive subjects with chronic HCV genotype 1 infection. SVR24planned is defined as having undetectable plasma HCV ribonucleic acid (RNA) levels 24 weeks after the last planned dose of study drugs.
Other Endpoints
Secondary Outcome Measures: - The safety and tolerability of the 2 dose regimens of telaprevir. [ Time Frame: 24 weeks after last planned intake of study medication. ] [ Designated as safety issue: No ] - The effect of IL28B genotype on viral response. [ Time Frame: 24 weeks after last planned intake of study medication ] [ Designated as safety issue: No ] - The pharmacokinetics of telaprevir, Peg-IFN-alpha-2a, and ribavirin and pharmacokinetic-pharmacodynamic relationships for safety and efficacy. [ Time Frame: 24 weeks after last planned intake of study medication ] [ Designated as safety issue: No ] - The changes from baseline in the amino acid sequence of the HCV NS3-4A region. [ Time Frame: 24 weeks after last planned intake of study medication ] [ Designated as safety issue: No ]
Start Date
2010-12-23
Primary Endpoints Reported
2012-10-01
Patient Population
Treatment-naive patients with genotype 1 hepatitis C.
Inclusion Criteria
Ages Eligible for Study: 18 Years to 70 Years Inclusion Criteria: - Patient has chronic HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL - Patients should not have had any previous treatment for hepatitis C - Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period - Patients with cirrhosis should have serum alpha-fetoprotein (AFP) < or = 50 ng/mL. If AFP > 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period - A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV. - Subject is judged to be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. - Subject or female partner is not pregnant, planning to become pregnant, or breastfeeding. All female subjects must have a negative serum --human chorionic gonadotropin (--hCG) pregnancy test at screening. - Subject is willing/able to adhere to the prohibitions and restrictions specified in this protocol. - Subject must have signed an Informed Consent Form (ICF) including consent to IL28B testing, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. - Subjects should agree not to participate in other clinical studies for the duration of their participation in this study, except for noninterventional or observational studies and only after prior approval of the sponsor.
Exclusion Criteria
Exclusion Criteria: - Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype. - Patient has a pre-existing psychiatric condition, including but not limited to: - Severe depression or hospitalization for depression. - Schizophrenia, bipolar illness, severe anxiety, or personality disorder. - A period of disability or impairment due to a psychiatric disease within the past 5 years. - Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C: history of ascites, hepatic encephalopathy, or bleeding esophageal varices, and/or any of the following screening laboratory results: - International Normalized Ratio (INR) of - 1.5; - Serum albumin < 3.3 g/dL; - Serum total bilirubin > 1.8 times upper limit of laboratory normal range (ULN), unless isolated or in subjects with Gilbert's Syndrome. - Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection - Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma). - Subject presents a contraindication to the administration of Peg-IFN-alfa-2a or RBV, including but not limited to any of the following: - hypersensitivity to Peg-IFN-alfa-2a, RBV, or any of their components; - hemoglobinopathies; - history or clinical evidence of significant cardiac disease and/or clinically significant ECG abnormalities; - abnormal thyroid function that is not adequately controlled; - poorly controlled diabetes mellitus as evidenced by hemoglobin A1c (HbA1c) - 8.5% at screening; - creatinine clearance - 50 mL/min at screening; - antinuclear antibody (ANA) titer - 1:640 at screening or other evidence of autoimmune-mediated disease. - Subject has known allergies, hypersensitivity, or intolerance to telaprevir or its excipients - Subject uses disallowed therapies. Subject has congenital or acquired prolonged QT interval, a history of nonsustained or sustained ventricular tachycardia, or a history of drug-induced QT prolongation and/or Torsade de Pointes. - Subject has history of organ transplant that requires chronic immunosuppression. Note: corneal, skin, and hair grafts are allowed. - Subject has a medical condition that requires chronic or intermittent use of systemic corticosteroids. - Subject has history or other evidence of clinically significant retinopathy or ophthalmological disorder, including but not limited to disorders due to diabetes mellitus or hypertension. Clearance by an ophthalmologist is required within 3 months prior to screening or within the screening period for all subjects with diabetes mellitus, hypertension, or known retinal disorders. The ophthalmologist should conduct a fundoscopic exam, which should be documented in the subjects' records. The findings of the exam must also be recorded on the electronic Case Report Form (eCRF). - Subject has clinical evidence of chronic pulmonary disease associated with functional impairment. - Subject has evidence of hemophilia or other bleeding disorder. - Subject has evidence of serious or severe bacterial or fungal infection(s), including active tuberculosis. - Subject has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection. - Subject has a history of acute or chronic pancreatitis. - Knowledge or suspicion exists of alcohol, barbiturate, or amphetamine recreational or narcotic drug use (current or within 2 years prior to the screening visit) that in the investigator's opinion would compromise the subject's safety and/or compliance with study procedures. - Subject has a condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting or performing study requirements. - Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator. - Subject received an investigational drug or used an investigational medical device within 90 days before the planned start of treatment. - Subject has a grade 4 laboratory abnormality as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events or any other clinically relevant abnormalities in the opinion of the investigator. Subjects with grade 4 elevations in gamma-glutamyltransferase (GGT) will be allowed to enter the study if there are no other clinically relevant laboratory abnormalities, as judged by the investigator. - Subject has history of seizure disorders - Knowledge or suspicion exists of alcohol, barbiturate, or amphetamine recreational or narcotic drug use (current or within 2 years prior to the screening visit) that in the investigator’s opinion would compromise the subject’s safety and/or compliance with study procedures.
Gender
Both
Age (Min)
18
Age (Min) Units
Years
Age (Max)
70
Age (Max) Units
Years
Prior/Concurrent Therapy
N/A
Target Accrual
704 [EEA- 352 patients, 40 subjects in Italy]
Reported Sites
135
Identified Sites
11
Actual Accrual
736
Trial Locations
Australia
Austria
Belgium
Brazil
Canada
EU
France
Germany
Global
Ireland
Italy
Mexico
Poland
Russia
Spain
Sweden
UK
US
Treatment Plan
N/A
Study Keywords
randomized open label global non inferiority international interventional efficacy parallel assignment multicenter
Study Design
Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment This is a Phase IIIb, non inferiority, global, multinational study. This is a multicenter study. This is a safety, pharmacokinetic-pharmacodynamic, bioequivalence, not controlled and stratified study.
Investigators / Contacts
Tibotec-Virco Virology BVBA Clinical Trial, Study Director, Tibotec BVBA Compound Development Team Leader, Responsible Party, Tibotec Pharmaceuticals, Ireland Contact: E-mail: info1@veritasmedicine.com Medisource Email: contact medisource@its.jnj.com
Notes
Study Timing Study Start Date: December 2010 Estimated Study Completion Date: October 2012 Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure) http://www.clinicaltrials.gov/ct2/show/NCT01241760

EU Clinical Trials Register as accessed on June 22, 2011 EudraCT Number: 2010-021628-84 Sponsor Protocol Number: VX-950-C211 Start Date: 12/23/2010 Country: GB(Ongoing) AT(Ongoing) IT(Ongoing) SE(Ongoing) Note: Number of anticipated sites, planned number of subjects, and estimated trial duration for each member state concerned (and in the EEA overall) are available at source. To access this information, search EudraCT as instructed below and click into each country code at main posting. Search with EudraCT Number: 2010-021628-84 https://www.clinicaltrialsregister.eu/ctr-search/

Excerpted from: Italian CTR [Accessed on June 07, 2011] [Translated from Italian] A phase 3, randomized, open telaprevir administered 2 times daily or every 8 hours in combination with pegylated interferon alfa-2a and ribavirin in naive patients with chronic hepatitis C genotype 1 The study is: Open from April 5, 2011 This is a study: Multicentre Number of planned centers in Italy: 13 Number of planned centers in Europe: 150 Life Expectancy for entry into Italy: 3 Months Expected duration of the study in its entirety in the world: 23 Months Countries where testing is carried out: Italy, European Union and other countries outside Europe Projected population: 40 subjects in Italy, 352 subjects in Europe, 704 people in the world [Original text] Uno studio di fase 3 randomizzato in aperto con telaprevir somministrato 2 volte al giorno od ogni 8 ore, in combinazione con interferone pegilato alfa-2a e ribavirina in pazienti naive affetti da infezione cronica da virus dell'epatite C di genotipo 1 Lo studio è: Aperto dal 05 APRILE 2011 Si tratta di uno studio: Multicentrico Numero di centri previsti in Italia: 13 Numero di centri previsti in Europa: 150 Durata prevista per l'arruolamento in Italia: 3 Mesi Durata prevista dello studio in toto nel mondo: 23 Mesi Paesi in cui viene svolta la sperimentazione: Italia, Unione Europea ed altri paesi extra europei Popolazione prevista: 40 soggetti in Italia, 352 soggetti in Europa, 704 soggetti nel mondo http://ricerca-clinica.agenziafarmaco.it/en/node/index.php?q=node/150&Cerca=studio&ID_STUD=48198&TIPOLOGIA=1&RICERCA_LIBERA=2010-021628-84

Locations/Contacts Study Sites and Contact information (Last Updated on April 26, 2011) [Last accessed on June 01, 2011]: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: info1@veritasmedicine.com United States, California Recruiting La Jolla, California, United States Recruiting Los Angeles, California, United States Recruiting San Diego, California, United States Not yet recruiting San Diego, California, United States United States, Colorado Recruiting Aurora, Colorado, United States United States, Connecticut Not yet recruiting Farmington, Connecticut, United States Recruiting New Haven, Connecticut, United States United States, Florida Recruiting Bradenton, Florida, United States Recruiting Jacksonville, Florida, United States United States, Georgia Recruiting Atlanta, Georgia, United States Recruiting Marietta, Georgia, United States United States, Illinois Recruiting Chicago, Illinois, United States Recruiting Downers Grove, Illinois, United States United States, Louisiana Recruiting New Orleans, Louisiana, United States United States, Maryland Not yet recruiting Lutherville, Maryland, United States United States, Massachusetts Not yet recruiting Boston, Massachusetts, United States United States, Missouri Recruiting Kansas City, Missouri, United States United States, New Hampshire Recruiting Lebanon, New Hampshire, United States United States, New Jersey Recruiting Egg Harbor Twp, New Jersey, United States United States, New Mexico Recruiting Santa Fe, New Mexico, United States United States, New York Recruiting New York, New York, United States United States, North Carolina Recruiting Charlotte, North Carolina, United States Recruiting Durham, North Carolina, United States Recruiting Statesville, North Carolina, United States Recruiting Winston Salem, North Carolina, United States United States, Ohio Recruiting Cincinnati, Ohio, United States United States, Oregon Not yet recruiting Portland, Oregon, United States United States, Pennsylvania Recruiting Allentown, Pennsylvania, United States Recruiting Hershey, Pennsylvania, United States Recruiting Philadelphia, Pennsylvania, United States Recruiting Pittsburgh, Pennsylvania, United States United States, Rhode Island Recruiting Providence, Rhode Island, United States United States, South Carolina Recruiting Charleston, South Carolina, United States Recruiting Columbia, South Carolina, United States United States, Tennessee Not yet recruiting Nashville, Tennessee, United States United States, Texas Recruiting Arlington, Texas, United States Recruiting Dallas, Texas, United States Recruiting Houston, Texas, United States Recruiting San Antonio, Texas, United States United States, Virginia Recruiting Falls Church, Virginia, United States Recruiting Norfolk, Virginia, United States United States, Washington Recruiting Seattle, Washington, United States Australia Recruiting Adelaide, Australia Recruiting Camperdown, Australia Recruiting Clayton, Australia Recruiting Darlinghurst, Australia Recruiting Fitzroy, Australia Recruiting Greenslopes, Australia Recruiting Melbourne, Australia Recruiting Perth, Australia Austria Recruiting Graz N/A, Austria Recruiting Linz, Austria Recruiting Wien, Austria Belgium Recruiting Antwerpen, Belgium Recruiting Brussels, Belgium Recruiting Genk, Belgium Not yet recruiting Gent, Belgium Recruiting Leuven, Belgium Recruiting Liege, Belgium Brazil Not yet recruiting Campinas, Brazil Not yet recruiting Salvador, Brazil Not yet recruiting Santo Andre, Brazil Not yet recruiting Sao Paulo, Brazil Recruiting São Paulo, Brazil France Recruiting Clichy, France Recruiting Creteil, France Recruiting Grenoble, France Recruiting Lille, France Recruiting Lyon, France Not yet recruiting Montpellier, France Recruiting Paris, France Recruiting Pessac, France Recruiting Vandoeuvre Les Nancy, France Recruiting Villejuif Cedex, France Germany Recruiting Berlin, Germany Recruiting Bochum, Germany Recruiting Essen, Germany Recruiting Frankfurt, Germany Recruiting Hamburg, Germany Recruiting Kiel, Germany Recruiting Mainz, Germany Recruiting Regensburg, Germany Ireland Recruiting Dublin, Ireland Recruiting Dublin 9, Ireland Mexico Recruiting Mex Ctity, Mexico Not yet recruiting Mexico, Mexico Recruiting Mexico, Mexico Recruiting Monterrey, Mexico Poland Recruiting Bialystok, Poland Recruiting Bydgoszcz, Poland Recruiting Czeladz, Poland Recruiting Kielce, Poland Recruiting Krakow, Poland Recruiting Warszawa, Poland Spain Not yet recruiting Barcelona, Spain Recruiting Barcelona N/A, Spain Not yet recruiting Madrid, Spain Recruiting Madrid, Spain Recruiting Malaga N/A, Spain Recruiting Santander N/A, Spain Recruiting Sevilla N/A, Spain Recruiting Valencia, Spain Not yet recruiting Valencia, Spain Sweden Recruiting Göteborg, Sweden Recruiting Malmö, Sweden Recruiting Stockholm, Sweden United Kingdom Recruiting Birmingham, United Kingdom Recruiting Edinburgh, United Kingdom Recruiting Glasgow, United Kingdom Recruiting London, United Kingdom Recruiting Manchester, United Kingdom [Content of the URL has changed] http://www.clinicaltrials.gov/ct2/show/study/NCT01241760

May 03, 2011 Excerpted from: Vertex Reports First Quarter 2011 Financial Results and Reviews Milestones for Key Development Programs - Hepatitis C: FDA decision on NDA for INCIVEK (telaprevir) expected this month CAMBRIDGE, Mass.--(BUSINESS WIRE)- Vertex Pharmaceuticals Incorporated...today provided an update on recent progress in its key development programs, discussed upcoming milestones and reported consolidated financial results for the quarter ended March 31, 2011... ...Recent Clinical Development Progress Hepatitis C: Preparing for Launch of INCIVEK (telaprevir) - Vertex today announced that it intends to use the name INCIVEK (in-SEE-veck) as the trade name for telaprevir. If approved, telaprevir will be marketed by Vertex as INCIVEK in the U.S. - Vertex recently completed its FDA Antiviral Drugs Advisory Committee meeting for INCIVEK (telaprevir). At the conclusion of the meeting, the committee voted unanimously (18-0) to recommend FDA approval of INCIVEK (telaprevir) for people with genotype 1 chronic hepatitis C who were not treated previously and those who were treated previously but not cured with currently available medicines. Vertex expects the FDA to provide its formal decision on the New Drug Application for INCIVEK (telaprevir) by May 23. - Vertex's collaborator, Janssen-Cilag International NV, is awaiting a formal decision from the European Medicines Agency (EMA) on its Marketing Authorisation Application (MAA) for telaprevir in the EU. The EMA accepted telaprevir for accelerated assessment, which is granted to new medicines of major public health interest. Vertex believes that Tibotec, a division of Janssen-Cilag, may receive a response on the MAA in the second half of 2011... ...Phase 3b Study of Twice-daily Dosing of INCIVEK (telaprevir) - Patient enrollment is ongoing in a Phase 3b clinical trial to evaluate twice-daily dosing of INCIVEK (telaprevir; 1,125 mg; BID) compared to three-times-daily dosing of INCIVEK (telaprevir; 750 mg; q8h) in combination with Pegasys (pegylated-interferon alfa-2a) and Copegus (ribavirin) for people with chronic genotype 1 hepatitis C. The study, known as OPTIMIZE, does not include a control arm of pegylated-interferon and ribavirin alone. Sustained viral response (SVR or viral cure) data from OPTIMIZE are expected as early as the second half of 2012, which could support the submission of a supplemental NDA for twice-daily (BID) dosing of INCIVEK (telaprevir) by the end of 2012... http://investors.vrtx.com/releasedetail.cfm?ReleaseID=574129

EU Clinical Trials Register as accessed on Jun 07, 2011 EudraCT Number: 2010-021628-84 Sponsor Protocol Number: VX-950-C211 Start Date: 10/08/2010 Country:GB(Ongoing) AT(Ongoing) SE(Ongoing) Note: Number of anticipated sites, planned number of subjects, and estimated trial duration for each member state concerned (and in the EEA overall) are available at source. To access this information, search EudraCT as instructed below and click into each country code at main posting. Search with EudraCT Number: 2010-021628-84 [Content of this URL has Changed] https://www.clinicaltrialsregister.eu/ctr-search/

Excerpted from: French Agency for the Safety of Health Products [Accessed on June 01, 2011]: [Translated from French] Essai clinique - N° EudraCT 2010-021628-84 Test Description Full track A randomized, open-label Phase 3 study of telaprevir Administered Twice daily Every 8 hours or in Combination With pegylated interferon alfa-2a and ribavirin in treatment-naive genotype 1 chronic Subjects With Hepatitis C virus infection Current status of trial: Not Started [More information about the trial] Disease (s) or condition (s) (s) concerned by the test Hepatitis C Virus (HCV) Rare disease: No [View MedDRA codes] Drug (s) experienced (s) [Tabular data available at the source URL:] [View (s) comparator (s) for the comparative tests, where appropriate] Persons undergoing testing Tranche (s) studied age (s): 18 to 65 years, Over 65 years Sex: Men Women [More information about the persons undergoing the test] Proponent Information: Name: Tibotec BVBA Status: Commercial Address: Turnhoutsebaan 30 Postal Code: 2340 City: Beerse Country: BELGIUM [Original text:] Clinical Trial - No EudraCT 2010-021628-84 Description de l'essai Titre complet A randomized, open-label, Phase 3 study of telaprevir administered twice daily or every 8 hours in combination with pegylated interferon alfa-2a and ribavirin in treatment-naive subjects with genotype 1 chronic hepatitis C virus infection Etat d'avancement de l'essai : Non débuté [Plus d'informations sur l'essai] Maladie(s) ou affection(s) concernée(s) par l'essai Hepatitis C Virus (HCV) Maladie rare: Non [Voir les codes MedDRA] Médicament(s) expérimenté(s) Personnes se prêtant à l'essai: Tranche(s) d'âge étudiée(s): De 18 à 65 ans, Plus de 65 ans Sexe: Hommes, Femmes [Plus d'informations sur les personnes se prêtant à l'essai] Information sur le promoteur Nom : Tibotec BVBA Statut : commercial Adresse : Turnhoutsebaan 30 Code Postal : 2340 Ville : Beerse Pays : BELGIQUE https://icrepec.afssaps.fr/Public/essai.php?num=2010-021628-84

November 02, 2010 Excerpted from: 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2010) Telaprevir Increases Sustained Response Rates and Shortens Treatment Duration for Newly Treated Hepatitis C Patients ...Vertex announced last week that partner Tibotec is starting a new multinational Phase 3 clinical trial for treatment-naive patients, called OPTIMIZE, looking at a more convenient regimen of telaprevir administered twice rather than 3-times-daily... http://www.hivandhepatitis.com/2010_conference/aasld/docs/1102_b.html

October 25, 2010 Vertex Pharmaceuticals Announces Start of a Phase 3b Study of Twice-Daily Telaprevir in People Not Treated Previously for Hepatitis C - First Phase 3 study to evaluate twice-daily (BID) dosing of a protease inhibitor for hepatitis C - - All patients will receive telaprevir-based combination therapy - CAMBRIDGE, Mass., Oct 25, 2010 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the initiation of a Phase 3b study called OPTIMIZE that will evaluate twice-daily (BID) dosing of a telaprevir-based combination regimen in people chronically infected with genotype 1 hepatitis C virus (HCV) who have not been treated previously. This is the first Phase 3 study to evaluate twice-daily dosing of a protease inhibitor for the treatment of hepatitis C. OPTIMIZE will not include a control arm of pegylated-interferon and ribavirin alone... ...The OPTIMIZE study will be conducted by Vertex's collaborator, Tibotec. OPTIMIZE Study Design ...OPTIMIZE is a randomized, open-label, Phase 3b study that will evaluate twice-daily dosing (BID) of telaprevir in people chronically infected with genotype 1 HCV who have not been treated previously. The study will be conducted globally at 135 clinical trial sites and enroll approximately 700 people. Patient screening for enrollment in the OPTIMIZE study is expected to start in November 2010. For the first 12 weeks of the study, all patients will receive 2,250mg of telaprevir taken twice daily (1,125mg; BID) or three times daily (750mg; every eight hours) in combination with pegylated-interferon alpha-2a (PEGASYS) and twice-daily ribavirin. Response guided therapy will be used to determine whether patients receive pegylated-interferon and ribavirin alone for an additional 12 weeks (24 weeks total) or 36 weeks (48 weeks total) based on their treatment response at week 4. The primary endpoint of the OPTIMIZE study is sustained viral response (SVR) 24 weeks after the end of all treatment. The primary objective is to demonstrate non-inferiority of BID telaprevir versus telaprevir dosed every eight hours as measured by SVR. SVR data from the study are expected as early as 2012. If these data are positive, they may support the submission of a supplemental New Drug Application (sNDA) for twice-daily (BID) dosing of telaprevir... http://investors.vrtx.com/releasedetail.cfm?ReleaseID=522614

September 28, 2010 JMP Securities LLC - Healthcare Focus Conference Vertex Pharmaceuticals Presentation Ian Smith - Vertex Pharmaceuticals Incorporated - EVP & CFO ...One of the key studies to continue to enhance the profile of the telaprevir based regimen is to move our dosing schedule from three times daily down to twice daily. We should commence that study before the end of the year.... ...We submitted a protocol earlier this year just before we had our registration data from the ADVANCE study in naives. Our protocol included a bid dosing, which is twice daily, a three times daily dosing, and the standard of care arm because it was a Phase 3 so we need to show we're at least equivalent to that that's on the market. ...The FDA actually asked us to remove the standard of care arm once they saw the ADVANCE data.... So that study will be head-to-head bid against tid, it'll be a non inferiority type study, probably 600 or more patients..... And that should start later this year. And starting later this year means we should be amending the label to bid dosing probably around 2013. [No URL available.]

Excerpted from: Vertex - Development Pipeline [Accessed on March 14, 2011] Product: Telaprevir (VX-950) Phase: Phase III Indication: HCV Infection [Content of the URL has changed] http://www.vrtx.com/current-projects.html

July 28, 2010 Excerpted from: Vertex Pharmaceuticals Reports Second Quarter 2010 Financial Results and Highlights Recent Business and Clinical Progress ...CAMBRIDGE, Mass., Jul 28, 2010 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today provided an update on recent progress in its development programs in hepatitis C virus (HCV) infection, cystic fibrosis (CF) and other diseases and reported consolidated financial results for the quarter ended June 30, 2010... ...Recent Clinical Development Progress ...Phase 3b Trial to Evaluate Twice-Daily (BID) Compared to Three-Times-Daily Dosing of Telaprevir - In the fourth quarter of 2010, Vertex and its collaborator Tibotec expect to initiate a Phase 3b clinical trial to evaluate twice-daily dosing of telaprevir (1,125 mg BID) compared to three-times-daily dosing of telaprevir (750 mg; q8h). This trial is expected to enroll approximately 700 treatment-naive people with genotype 1 hepatitis C in two telaprevir-based treatment arms and will be conducted in the U.S., E.U. and certain other countries. Based on advice from regulatory authorities in the U.S. and E.U., the trial will not include a control arm of pegylated-interferon and ribavirin... http://investors.vrtx.com/releasedetail.cfm?ReleaseID=493622

May 11, 2010 Vertex Pharmaceuticals Presentation at the Bank of America Merrill Lynch Health Care Conference During the Q&A session, Vertex stated that it expects to initiate a Phase III study evaluating twice daily dosing of telaprevir, in support of a future SNDA filing. The company will be designing this trial in the second half of 2010 and hopes to initiate the trial prior to year end. [URL temporarily available at:] http://investors.vrtx.com/eventdetail.cfm?eventid=80832

May 14, 2009 [Translated from French] Excerpted from: French Agency for the Safety of Health Products Doc. Ref: RePEc 14/05/2009 DIRECTORY OF PUBLIC AUTHORIZED CLINICAL TRIALS INFORMATION ON THE TEST (IN FRENCH) (as reported by the trial sponsor) 1. Full title of biomedical research Study of phase 3, randomized, open, comparing the telaprevir administered twice a day telaprevir administered every 8 hours in combination with pegylated interferon alpha-2a and ribavirin in patients with chronic hepatitis C, genotype 1 and treatment-naive 2. Short title and easily understandable Research 3. Medical condition or disease being studied Hepatitis C virus (HCV) infection, genotype 1 4. Brief description of research easily understandable This is a Phase 3, randomized, open, multicenter, in which patients with chronic hepatitis C, genotype 1 treatment-naive, will be randomized to one of two treatment groups as follows: - Telaprevir taken at a dose of 750 mg every 8 hours - Telaprevir taken at a dose of 1125 mg twice daily The telaprevir is administered in combination with pegylated interferon alpha-2a and Ribavirin. The main objective of the trial is to demonstrate non-inferiority of virologic response (SVR) at 24 weeks of telaprevir administered at a dose of 1125 mg twice daily (bid) compared to the administered dose telaprevir 750 mg every 8 hours in combination with pegylated interferon (PEG-IFN alpha-2a) and ribavirin (RBV). About 45 patients in France will be included in this study and followed for 72 weeks. Participation in other experimental studies or taking another experimental treatment while participating in this study will not be permitted. 5. List of countries in which it is intended to include people in research Australia, Austria, Belgium, Brazil, Canada, France, Germany, Italy, Poland, Spain, Sweden, United Kingdom, Russia, USA and Mexico 6. Origin of research funding Organization Name Tibotec BVBA Country Belgium 7. Contact Information in France designated the developer for questions about research Tibotec BVBA Proponent Name Contact Name Medisource Email contact medisource@its.jnj.com [Original text] Doc. réf : Repec 14.05.09 1. Titre complet de la recherche biomédicale Etude de phase 3, randomisée, en ouvert, comparant le telaprevir administré deux fois par jour au telaprevir administré toutes les 8 heures en association avec l’interféron pégylé alpha-2a et la ribavirine chez des patients présentant une hépatite C chronique, de génotype 1, et naïfs de traitements 2. Titre abrégé et facilement compréhensible de la recherche 3. Condition médicale ou pathologie étudiée Virus de l’hépatite C (VHC) chronique, de génotype 1 4. Brève description facilement compréhensible de la recherche Il s’agit d’une étude de phase 3, randomisée en ouvert, multicentrique, dans laquelle des patients présentant une hépatite C chronique, de génotype 1 et naïfs de traitement, seront randomisés dans l’un des 2 groupes de traitements suivants: - Telaprevir pris à la dose de 750 mg toutes les 8 heures, - Telaprevir pris à la dose de 1125 mg deux fois par jour Le telaprevir est administré en association avec l’interféron pégylé alpha-2a et la Ribavirine. L’objectif principal de l’essai est de démontrer la non-infériorité de la réponse virologique soutenue (RVS) à 24 semaines du telaprevir administré à la dose de 1125 mg deux fois par jour (b.i.d) par rapport au telaprevir administré à la dose de 750 mg toutes les 8 heures et administré en association avec l’interféron pégylé (PEG-IFN-alpha-2a) et la ribavirine (RBV). Environ 45 patients en France seront inclus dans cette étude et seront suivis pendant 72 semaines. La participation à d’autres études expérimentales ou la prise d’un autre traitement expérimental tout en participant à cette étude ne sera pas autorisée. 5. Liste des pays dans lesquels il est prévu d’inclure des personnes dans la recherche Australie, Autriche, Belgique, Brésil, Canada, France, Allemagne, Italie, Pologne, Espagne, Suède, Royaume-Uni, Russie, États-Unis et Mexique 6. Origine du financement de la recherche Nom de l’organismeTibotec BVBA PaysBelgium 7. Coordonnées du contact en France désigné par le promoteur pour toute question sur la recherche Nom du promoteur Tibotec BVBA Nom du contactMedisource Adresse électronique du contactmedisource@its.jnj.com https://icrepec.afssaps.fr/Public/download.php?file=2010-021628-84_DESC.doc
Trial Tags
PGX, Registration
Supporting URLs
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=493622
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=522614
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=574129
http://ricerca-clinica.agenziafarmaco.it/en/node/index.php?q=node/150&Cerca=centri&ID_STUD=48198&TIPOLOGIA=1
http://ricerca-clinica.agenziafarmaco.it/en/node/index.php?q=node/150&Cerca=studio&ID_STUD=48198&TIPOLOGIA=1&RICERCA_LIBERA=2010-021628-84
http://www.clinicaltrials.gov/ct2/show/NCT01241760
http://www.hivandhepatitis.com/2010_conference/aasld/docs/1102_b.html
http://www.medicine.ufl.edu/gastro/gastro_liverUnitClinicalTrials.asp
http://www.vrtx.com/current-projects.html
https://icrepec.afssaps.fr/Public/download.php?file=2010-021628-84_DESC.doc
https://icrepec.afssaps.fr/Public/essai.php?num=2010-021628-84
https://www.clinicaltrialsregister.eu/ctr-search/
Last Modified
2011-07-19
Last Full Review
2011-06-14
Internal Comments
N/A
Record URL
http://jnj.citeline.com/xt_view.asp?trialid=126829&target=10
Record Number
126829
Drug Name(s)
telaprevir
peginterferon alfa-2a (SC)
ribavirin, Roche

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A Randomized, Open-label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-naive Subjects With Genotype 1 Chronic Hepatitis C Virus Infection.
700060567


Study Details
Purpose
This trial will compare the efficacy of two regimens of telaprevir [750mg three-times-daily vs 1125mg twice-daily; Vertex Pharmaceuticals] in combination with ribavirin and peginterferon alfa-2a in treatment-naive patients with genotype 1 chronic hepatitis C. The primary endpoint is proportion of patients achieving undetectable plasma hepatitis C virus RNA levels. This will be assessed at 24 weeks.
Start Date: 01 Dec 2010 (actual)
End Date: 01 Oct 2012 (planned)

Details Study Design: multicentre, open, parallel, randomised
Study Controls: baseline comparison; drug regimen comparison
Study Status: Active, no longer recruiting
Study Phase: III
Study Location: Australia Austria Belgium Brazil England France Germany Ireland Mexico Multinational Poland Scotland Spain Sweden USA
Study Endpoint: Pharmacokinetic parameters, Sustained virological response rate, Viral load, Virological response

Subjects Type: patients
Number: 742
Age: 18-70 years, adult, elderly

Patient Inclusion: Aged 18-70 years; patient has chronic HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL - Patients should not have had any previous treatment for hepatitis C - Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period - Patients with cirrhosis should have serum alpha-fetoprotein (AFP) <= 50 ng/mL. If AFP > 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period - A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV.
Patient Exclusion: Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype - Patient has a pre-existing psychiatric condition - Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C - Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection - Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).

Ongoing Trial Comments
The trial results data, if favourable, will be used to support the submission of a supplemental NDA for twice-daily dosing of telaprevir in patients with genotype 1 chronic hepatitis C.

Study Centre Details
NameCountryInvestigatorsContact Details
   E-mail: info1@veritasmedicine.com
Johnson and Johnson Pharmaceutical Research and Development  
Tibotec BVBA  
Tibotec PharmaceuticalsIreland 
Vertex Pharmaceuticals, CambridgeUSAKauffman R 

Study Status History
DateEventCommentUpdate Date
03/08/2011Other trial eventProfile reviewed.03/08/2011
29/07/2011Status change - active, no longer recruitingStatus changed from recruiting to active, no longer recruiting.02/08/2011
22/07/2011Other trial eventLast checked against ClinicalTrials.gov record.29/07/2011
02/06/2011Other trial eventNew source identified (European Clinical Trials Database record EudraCT2010-021628-84)02/06/2011
04/05/2011Other trial eventData from this study could support the submission of a supplemental NDA for twice daily dosing of telaprevir, according to a Vertex Pharmaceuticals media release.17/05/2011
04/05/2011Other trial eventSustained viral response data are expected in the second half of 2012, according to a Vertex Pharmaceuticals media release.17/05/2011
07/01/2011Other trial eventActual initiation date (December 2010) added as reported by ClinicalTrials.gov.12/01/2011
03/12/2010Completion datePlanned end date (1 Oct 2012) added as reported by ClinicalTrials.gov.07/12/2010
03/12/2010Status change - recruitingStatus changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov.07/12/2010
15/11/2010Other trial eventNew source identified and integrated (ClinicalTrials.gov. NCT01241760).07/12/2010
26/10/2010Other trial eventPatient screening for enrollment is expected start in November 2010 and results are are expected as early as 2012, according to a Vertex Pharmaceuticals media release.26/10/2010
26/10/2010New trial recordNew trial record26/10/2010

Disease Treated
IndicationPatient Segment
Hepatitis-Cgenotype 1
Hepatitis-Ctreatment-naive

Treatments
NameDoseRouteFreqDur.
Peginterferon alfa-2a180 µg/weekSC inj1/week24 or 48 weeks
Peginterferon-alfa-2a180 µg/weekSC inj1/week24 or 48 weeks
Ribavirin1000-1200 mg/dayPObid24 or 48 weeks
Telaprevir2250 mg/dayPObid12 weeks
Telaprevir2250 mg/dayPOq8h12 weeks


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Trial Identifier
CR017608
VX-950HEP1001
NCT01253551
Trial Title
VX-950HEP1001 - Drug-drug Interaction Study Between Telaprevir and Raltegravir
Original Title
A Phase 1, Open-label, Randomized, Crossover Study in 20 Healthy Subjects to Investigate the Potential Pharmacokinetic Interaction Between Telaprevir and Raltegravir, Both at Steady-state
Sponsor(s)
Tibotec BVBA
Vertex Pharmaceuticals Incorporated
Source
Tibotec BVBA
Oversight
United States: Food and Drug Administration
USA: FOOD AND DRUG ADMINISTRATION - CENTER FOR DRUG EVALUATION AND RESEARCH
Brief Summary
The purpose of this study is to confirm the absence of a clinically relevant interaction between telaprevir and raltegravir at steady-state.Telaprevir is being investigated for the treatment of chronic hepatitis C virus infection, and raltegravir is used to treat HIV infection.
Detailed Description
This is an open-label, randomized (the order in which you receive the treatment sessions is determined by chance, like tossing a coin), crossover (participants will receive different interventions sequentially during the trial) study in healthy participants to investigate the effect of telaprevir 750 mg, every 8 hours, on the pharmacokinetics (how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body) of raltegravir 400 mg, twice a day, and vice versa. The study population will consist of 20 healthy participants. Each individual participant will receive two treatments: Treatment A (telaprevir 750 mg, every 8 hours, alone, on Days 1 to 6, with a morning dose on Day 7) and Treatment B (raltegravir 400 mg, twice a day, on Days 1 to 10 and telaprevir 750 mg, every 8 hours, on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11). Half of the participants will receive first Treatment A and then Treatment B; the other half will receive first Treatment B and then Treatment A. There will be a washout period of at least 14 days between the 2 sessions. The screening period will be maximum 21 days; the treatment duration will be approximately 4.5 weeks, and the follow-up period will be 30 to 31 days. All study medication will be taken with food. On Day 7 of Treatment A and Day 11 of Treatment B, 9 blood samples will be taken for determination of the levels of telaprevir in the blood. On Days 4 and 11 of Treatment B, 10 blood samples will be taken for determination of the levels of raltegravir in the blood. Predose pharmacokinetic samples will be collected on other days during the treatment sessions. Safety and tolerability will be evaluated throughout the trial by evaluating results of blood and urine analyses, vital signs, physical examinations, electrocardiograms (electrical recording of the heart), drug and alcohol screenings, and by assessing how the participant is feeling. In Treatment A, participants will receive 2 oral tablets of telaprevir 375 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. In Treatment B, participants will receive 1 oral tablet of 400 mg raltegravir twice a day on Days 1 to 10 and 2 oral tablets of 375 mg telaprevir every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.
Overall Status
Completed
Start Date
January 2011
Phase
Phase 1
Study Type
Interventional
Study Design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
# Arms
2
Enrollment
22 (Actual)
Eligibility Criteria
Inclusion Criteria:

- Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests at screening

- A Body Mass Index of 18.0 to 30.0 kg/m2, extremes included

- Women must be postmenopausal for at least 2 years, be surgically sterile and should not be breastfeeding

- Men must agree to use 2 highly effective methods of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of the study drug

- Be non-smoking for at least 3 months prior to selection.

Exclusion Criteria:

- Current use of prescription medication, regular treatment with over-the-counter medications (to be stopped no less than 7 days prior to first intake of study medication) or consumption of herbal medications or dietary supplements, vitamins, grapefruit or grapefruit juice, apple juice or orange juice within 14 days before first intake of study medication

- Consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week (1 unit of alcohol equals 1 glass of beer, 1 glass of wine, 25 mL shot of 40% spirit), consumption of alcohol 72 hours before or after study medication intake, consumption of an average of more than five 240 mL servings of coffee or other caffeinated beverages, eg, tea, cola per day

- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use

- Received an investigational drug or vaccine or used an investigational medical device within 3 months or 5 half lives (whichever is longer) before the planned start of treatment or having participated previously in a study with telaprevir.
Gender
Both
Minimum Age
18 Years
Maximum Age
55 Years
Healthy Volunteers?
Accepts Healthy Volunteers
Last Changed Date
2011-07-21
Interventions
NameTypeDescriptionGroup
Treatment sequence BADrugTreatment A: telaprevir 750 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.002
Treatment sequence ABDrugTreatment A: telaprevir 750 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.001
Drugs
Treatment sequence BA
Treatment sequence AB
Primary Outcome
Blood levels of telaprevir and raltegravir when given alone versus when given together
Blood levels of telaprevir and raltegravir when given alone versus when given together
Blood levels of telaprevir and raltegravir when given alone versus when given together
Secondary Outcome
Percentage of participants with a given adverse event as a measure of safety and tolerability [Safety Issue]
Clinical laboratory abnormalities as a measure of safety and tolerability [Safety Issue]
Clinical laboratory abnormalities as a measure of safety and tolerability [Safety Issue]
Clinical laboratory abnormalities as a measure of safety and tolerability [Safety Issue]
Vital signs observed values and changes from baseline as a measure of safety and tolerability [Safety Issue]
Vital signs observed values and changes from baseline as a measure of safety and tolerability [Safety Issue]
Vital signs observed values and changes from baseline as a measure of safety and tolerability [Safety Issue]
Physical examination findings and changes from baseline as a measure of safety and tolerability [Safety Issue]
Condition
Hepatitis C
Overall Official
Tibotec Pharmaceuticals Clinical Trial
Study Director
Tibotec Pharmaceutical Limited
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Laurent COTTE, MD
Principal Investigator
Hopital Croix Rousse LYON FRANCE
Jean-Pierre ABOULKER, MD
Study Chair
INSERM SC10 VILLEJUIF FRANCE
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Michael Adler, MD, PhD
Principal Investigator
Erasmus Hospital Bruxelles
Hendrik Reesink, MD, PhD
Principal Investigator
Academic Medical Center of the University of Amsterdam
Kenneth Sherman, MD, PhD
Principal Investigator
University of Cincinnati
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Tadashi Yoshida, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Nathalie Adda, MD
Study Director
Vertex Pharmaceuticals Incorporated
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Num. Locations
0
Num. Recruiting
0

Information obtained from ClinicalTrials.gov on September 11, 2011

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Trial Title
A Phase 1, Open-label, Randomized, Crossover Study in 20 Healthy Subjects to Investigate the Potential Pharmacokinetic Interaction Between Telaprevir and Raltegravir, Both at Steady-state.
Disease Type
HCV
HIV
Trial Phase
I
Patient Segment
(N/A)
Sponsorship
Johnson & Johnson/Janssen Biotech/Tibotec {J&J/Centocor Ortho Biotech/Tibotec Therapeutics {J&J/Ortho Biotech/Tibotec}}
Vertex
Primary Drugs
raltegravir (tablet)
telaprevir
Trial Identifier
CR017608
NCT01253551
TrialTroveID-138822
VX-950HEP1001
Trial Status
Completed
Trial Objectives
To confirm the absence of a clinically relevant interaction between telaprevir and raltegravir at steady-state. To investigate the effect of telaprevir 750 mg, every 8 hours, on the pharmacokinetics of raltegravir 400 mg, twice a day, and vice versa.
Primary Endpoints
Primary Outcome Measures: - Blood levels of telaprevir and raltegravir when given alone versus when given together [ Time Frame: Day 7 of Treatment A ] [ Designated as safety issue: No ] - Blood levels of telaprevir and raltegravir when given alone versus when given together [ Time Frame: Day 4 of Treatment B ] [ Designated as safety issue: No ] - Blood levels of telaprevir and raltegravir when given alone versus when given together [ Time Frame: Day 11 of Treatment B ] [ Designated as safety issue: No ]
Other Endpoints
Secondary Outcome Measures: - Vital signs observed values and changes from baseline as a measure of safety and tolerability [ Time Frame: At screening and at 5-7 days and 30-32 days after last dose (Treatment A or B) ] [ Designated as safety issue: Yes ] - Vital signs observed values and changes from baseline as a measure of safety and tolerability [ Time Frame: On Days 1 and 7 (Treatment A) ] [ Designated as safety issue: Yes ] - Vital signs observed values and changes from baseline as a measure of safety and tolerability [ Time Frame: On Days 1, 4, and 11 (Treatment B) ] [ Designated as safety issue: Yes ] - Physical examination findings and changes from baseline as a measure of safety and tolerability [ Time Frame: At screening, on Day -1 of Treatments A and B, and at 5-7 days and 30-32 days after last dose (Treatment A or B) ] [ Designated as safety issue: Yes ] - Percentage of participants with a given adverse event as a measure of safety and tolerability [ Time Frame: From screening to end of study ] [ Designated as safety issue: Yes ] - Clinical laboratory abnormalities as a measure of safety and tolerability [ Time Frame: At screening and at 5-7 days and 30-32 days after last dose (Treatment A or B) ] [ Designated as safety issue: Yes ] - Clinical laboratory abnormalities as a measure of safety and tolerability [ Time Frame: On Days 1 and 7 (Treatment A) ] [ Designated as safety issue: Yes ] - Clinical laboratory abnormalities as a measure of safety and tolerability [ Time Frame: On Days 1, 4, and 11 (Treatment B) ] [ Designated as safety issue: Yes ]
Start Date
2011-01-01
Primary Endpoints Reported
2011-04-01
Patient Population
Healthy adults.
Inclusion Criteria
Ages Eligible for Study: 18 Years to 55 Years Inclusion Criteria: - Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests at screening - A Body Mass Index of 18.0 to 30.0 kg/m^2, extremes included - Women must be postmenopausal for at least 2 years, be surgically sterile and should not be breastfeeding - Men must agree to use 2 highly effective methods of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of the study drug - Be non-smoking for at least 3 months prior to selection.
Exclusion Criteria
Exclusion Criteria: - Current use of prescription medication, regular treatment with over-the-counter medications (to be stopped no less than 7 days prior to first intake of study medication) or consumption of herbal medications or dietary supplements, vitamins, grapefruit or grapefruit juice, apple juice or orange juice within 14 days before first intake of study medication - Consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week (1 unit of alcohol equals 1 glass of beer, 1 glass of wine, 25 mL shot of 40% spirit), consumption of alcohol 72 hours before or after study medication intake, consumption of an average of more than five 240 mL servings of coffee or other caffeinated beverages, eg, tea, cola per day - History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use - Received an investigational drug or vaccine or used an investigational medical device within 3 months or 5 half lives (whichever is longer) before the planned start of treatment or having participated previously in a study with telaprevir.
Gender
Both
Age (Min)
18
Age (Min) Units
Years
Age (Max)
55
Age (Max) Units
Years
Prior/Concurrent Therapy
N/A
Target Accrual
20
Reported Sites
1
Identified Sites
0
Actual Accrual
4
Trial Locations
US
Treatment Plan
N/A
Study Keywords
interventional randomized crossover assignment open label
Study Design
Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Investigators / Contacts
Compound Development Team Leader, Study director, Tibotec-Virco Virology BVBA Contact: E-mail: info1@veritasmedicine.com
Notes
Study Timing: Study Start Date: January 2011 Study Completion Date: April 2011 http://www.clinicaltrials.gov/ct2/show/NCT01253551

Locations/Contacts Study Site and Contact information (Last Updated on March 3, 2011) [Last accessed on May 5, 2011] Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: info1@veritasmedicine.com United States, New Jersey Recruiting Neptune, New Jersey, United States [Content of the URL has changed] http://www.clinicaltrials.gov/ct2/show/NCT01253551

Detailed Treatment plan: This is an open-label, randomized (the order in which you receive the treatment sessions is determined by chance, like tossing a coin), crossover (participants will receive different interventions sequentially during the trial) study in healthy participants to investigate the effect of telaprevir 750 mg, every 8 hours, on the pharmacokinetics (how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body) of raltegravir 400 mg, twice a day, and vice versa. The study population will consist of 20 healthy participants. Each individual participant will receive two treatments: Treatment A (telaprevir 750 mg, every 8 hours, alone, on Days 1 to 6, with a morning dose on Day 7) and Treatment B (raltegravir 400 mg, twice a day, on Days 1 to 10 and telaprevir 750 mg, every 8 hours, on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11). Half of the participants will receive first Treatment A and then Treatment B; the other half will receive first Treatment B and then Treatment A. There will be a washout period of at least 14 days between the 2 sessions. The screening period will be maximum 21 days; the treatment duration will be approximately 4.5 weeks, and the follow-up period will be 30 to 31 days. All study medication will be taken with food. On Day 7 of Treatment A and Day 11 of Treatment B, 9 blood samples will be taken for determination of the levels of telaprevir in the blood. On Days 4 and 11 of Treatment B, 10 blood samples will be taken for determination of the levels of raltegravir in the blood. Predose pharmacokinetic samples will be collected on other days during the treatment sessions. Safety and tolerability will be evaluated throughout the trial by evaluating results of blood and urine analyses, vital signs, physical examinations, electrocardiograms (electrical recording of the heart), drug and alcohol screenings, and by assessing how the participant is feeling. In Treatment A, participants will receive 2 oral tablets of telaprevir 375 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. In Treatment B, participants will receive 1 oral tablet of 400 mg raltegravir twice a day on Days 1 to 10 and 2 oral tablets of 375 mg telaprevir every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11. http://www.clinicaltrials.gov/ct2/show/NCT01253551
Supporting URLs
http://www.clinicaltrials.gov/ct2/show/NCT01253551
Last Modified
2011-06-04
Last Full Review
2011-06-04
Internal Comments
N/A
Record URL
http://jnj.citeline.com/xt_view.asp?trialid=138822&target=10
Record Number
138822
Drug Name(s)
raltegravir (tablet)
telaprevir

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A Phase 1, Open-label, Randomized, Crossover Study in 20 Healthy Subjects to Investigate the Potential Pharmacokinetic Interaction Between Telaprevir and Raltegravir, Both at Steady-state
700192083


Study Details
Purpose
This study will investigate clinically relevant interactions between telaprevir and raltegravir at steady-state in volunteers. The primary endpoint will be blood levels of telaprevir and raltegravir when given alone versus when given together. This will be assessed at day 7 of telaprevir treatment and days 4 and 11 of raltegravir + telaprevir treatment.
Start Date: 01 Jan 2011 (actual)
End Date: 01 Apr 2011 (actual)

Details Study Design: crossover, open, randomised
Study Controls: drug combination comparison
Study Status: Completed
Study Phase: I
Study Location: USA
Study Endpoint: Drug concentration

Subjects Type: volunteers
Number: 22
Age: 18-55 years, adult

Patient Inclusion: Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests at screening - A Body Mass Index of 18.0 to 30.0 kg/m2, extremes included - Women must be postmenopausal for at least 2 years, be surgically sterile and should not be breastfeeding - Men must agree to use 2 highly effective methods of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of the study drug - Be non-smoking for at least 3 months prior to selection.; 18-55 years of age.
Patient Exclusion: Current use of prescription medication, regular treatment with over-the-counter medications (to be stopped no less than 7 days prior to first intake of study medication) or consumption of herbal medications or dietary supplements, vitamins, grapefruit or grapefruit juice, apple juice or orange juice within 14 days before first intake of study medication - Consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week (1 unit of alcohol equals 1 glass of beer, 1 glass of wine, 25 mL shot of 40% spirit), consumption of alcohol 72 hours before or after study medication intake, consumption of an average of more than five 240 mL servings of coffee or other caffeinated beverages, eg, tea, cola per day - History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use - Received an investigational drug or vaccine or used an investigational medical device within 3 months or 5 half lives (whichever is longer) before the planned start of treatment or having participated previously in a study with telaprevir.

Study Centre Details
NameCountryInvestigatorsContact Details
   E-mail: info1@veritasmedicine.com
NeptuneUSA 
Tibotec BVBA  
Vertex Pharmaceuticals Incorporated   

Study Status History
DateEventCommentUpdate Date
29/07/2011Other trial eventProfile reviewed.29/07/2011
21/07/2011Other trial eventLast checked against ClinicalTrials.gov record.29/07/2011
02/06/2011Status change - completedStatus changed from recruiting to completed as reported by ClinicalTrials.gov.07/06/2011
03/02/2011Status change - recruitingStatus changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov.10/02/2011
13/12/2010New trial recordNew trial record13/12/2010

Disease Treated
IndicationPatient Segment
Hepatitis-C
HIV-infections 

Treatments
NameDoseRouteFreqDur.
Raltegravir400 mgPOsingle dosesingle dose
Raltegravir800 mg/dayPObid10 days
Telaprevir2250 mg/dayPOtid5 days
Telaprevir2250 mg/dayPOtid6 days
Telaprevir750 mg/dosePO 2 doses
Telaprevir750 mgPOsingle dosesingle dose


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5.1 ClinicalTrials.Gov

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Trial Identifier
VX10-950-024
NCT01275599
Trial Title
Drug-Drug Interaction Study Between Telaprevir and Buprenorphine
Original Title
A Phase 1, Open-Label, Single-Sequence Study to Examine the Effect of Telaprevir on the Pharmacokinetics of Buprenorphine in Subjects on Stable Buprenorphine/Naloxone Maintenance Therapy
Sponsor(s)
Vertex Pharmaceuticals Incorporated
Tibotec BVBA
Source
Vertex Pharmaceuticals Incorporated
Oversight
United States: Food and Drug Administration
Brief Summary
The purpose of this study is to investigate the drug-drug interaction potential between telaprevir and buprenorphine/naloxone. An understanding of the interaction potential will help to determine whether buprenorphine dose adjustments are necessary for patients who are concomitantly treated with telaprevir.

Telaprevir, in combination with other antiviral agents, is being investigated for the treatment of chronic hepatitis C virus infection. Buprenorphine/naloxone is used for maintainance therapy in patients with opioid dependence.
Overall Status
Completed
Start Date
January 2011
Completion Date
April 2011 (Actual)
Phase
Phase 1
Study Type
Interventional
Study Design
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
# Arms
1
Enrollment
16 (Anticipated)
Eligibility Criteria
Inclusion Criteria:

- Males or females between the ages of 18 and 64 years, inclusive. Females must be of non-childbearing potential.

- Receiving once daily buprenorphine/naloxone maintenance therapy at a stable dose not exceeding 24 mg/6 mg, respectively, for at least 2 weeks prior to screening.

Exclusion Criteria:

- Illicit use of drugs such as cocaine, amphetamines and methylenedioxymethamphetamine (MDMA), barbiturates, benzodiazepines, tricyclic antidepressants, methadone or opiates/opioids (apart from buprenorphine).

- Treatment with any investigational drug within the last 30 days, or 5 half-lives, whichever is longer.

- Blood donation of 500 mL or more within the last 56 days.

- Infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
Gender
Both
Minimum Age
18 Years
Maximum Age
64 Years
Healthy Volunteers?
No
Countries
United States
Last Changed Date
2011-06-07
Interventions
NameTypeDescriptionGroup
telaprevirDrugTwo 375 mg tablets administered every 8 hours on Day 1 through Day 7, inclusive.Open-Label Arm
buprenorphine/naloxoneDrugBuprenorphine/naloxone sublingual tablets or films contain buprenorphine HCl and naloxone HCl dihydrate at a ratio of 4:1 buprenorphine:naloxone (ratio of free bases). In this study buprenorphine/naloxone will be dosed from Day -14 through Day 38, inclusive. From Day -14 through Day -1 all subjects will receive a maximum of 24 mg/6 mg of buprenorphine/naloxone. Subjects will not be permitted to change their dose during the telaprevir co-administration period (Day 1 through Day 7) unless warranted by the investigator's clinical judgment of subject safety. After Day 8, the dose of buprenorphine/naloxone may be adjusted if deemed necessary by the investigator.Open-Label Arm
Drugs
telaprevir
buprenorphine/naloxone
Primary Outcome
Blood levels of buprenorphine
Blood levels of norbuprenorphine
Blood levels of naloxone
Blood levels of telaprevir
Secondary Outcome
Safety and tolerability [Safety Issue]
Buprenorphine withdrawal symtoms
Condition
Hepatitis C
Opioid-Related Disorders
Overall Official
Tibotec Pharmaceuticals Clinical Trial
Study Director
Tibotec Pharmaceutical Limited
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Laurent COTTE, MD
Principal Investigator
Hopital Croix Rousse LYON FRANCE
Jean-Pierre ABOULKER, MD
Study Chair
INSERM SC10 VILLEJUIF FRANCE
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Michael Adler, MD, PhD
Principal Investigator
Erasmus Hospital Bruxelles
Hendrik Reesink, MD, PhD
Principal Investigator
Academic Medical Center of the University of Amsterdam
Kenneth Sherman, MD, PhD
Principal Investigator
University of Cincinnati
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Tadashi Yoshida, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Nathalie Adda, MD
Study Director
Vertex Pharmaceuticals Incorporated
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Andrew H. Talal, MD, MPH
Principal Investigator
Weill Medical College of Cornell University
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Tadashi Yoshida, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Steven Lidofsky, MD
Principal Investigator
University of Vermont & Fletcher Allen Health Care
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Paul Y Kwo, MD
Principal Investigator
Indiana University, Department of Medicine, Division of Gastroenterology/Hepatology
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Scott McCallister, M.D.
Study Director
Vertex Pharmaceuticals Incorporated
Num. Locations
2
Num. Recruiting
0

Information obtained from ClinicalTrials.gov on September 11, 2011

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Trial Title
A Phase 1, Open-Label, Single-Sequence Study to Examine the Effect of Telaprevir on the Pharmacokinetics of Buprenorphine in Subjects on Stable Buprenorphine/Naloxone Maintenance Therapy.
Disease Type
HCV
Trial Phase
I
Patient Segment
(N/A)
Sponsorship
Johnson & Johnson/Janssen Biotech/Tibotec {J&J/Centocor Ortho Biotech/Tibotec Therapeutics {J&J/Ortho Biotech/Tibotec}}
Vertex
Primary Drugs
buprenorphine + naloxone
telaprevir
Trial Identifier
NCT01275599
TrialTroveID-143219
VX10-950-024
Trial Status
Completed
Trial Objectives
To investigate the drug-drug interaction potential between telaprevir and buprenorphine/naloxone. To determine whether buprenorphine dose adjustments are necessary for patients who are concomitantly treated with telaprevir.
Primary Endpoints
Primary Outcome Measures: - Blood levels of buprenorphine [Time Frame: Day -4 through Day 38] [Designated as safety issue: No] - Measured by maximum observed concentration (Cmax), minimum observed concentration (Cmin), time of the maximum concentration (tmax), area under the time curve (AUC) from the time of study drug administration, zero to tau, where tau is the dosing interval. - Blood levels of norbuprenorphine [Time Frame: Day -4 through Day 38] [Designated as safety issue: No] - Measured by maximum observed concentration (Cmax), minimum observed concentration (Cmin), time of the maximum concentration (tmax), area under the time curve (AUC) from the time of study drug administration, zero to tau, where tau is the dosing interval. - Blood levels of naloxone [Time Frame: Day -1 and Day 7] [Designated as safety issue: No] - Measured by maximum observed concentration (Cmax) - Blood levels of telaprevir [Time Frame: Day 1 through Day 7 ] [ Designated as safety issue: No] - Measured by maximum observed concentration (Cmax), minimum observed concentration (Cmin), time of the maximum concentration (tmax), area under the time curve (AUC) from the time of study drug administration, zero to tau, where tau is the dosing interval.
Other Endpoints
Secondary Outcome Measures: - Safety and tolerability [Time Frame: Day -14 through Day 38] [Designated as safety issue: Yes] - Measured by incidence of treatment-emergent adverse events, clinical laboratory assessments, electrocardiogram outcomes, and vital signs. - Buprenorphine withdrawal symtoms [Time Frame: Day -2 through Day 38] [Designated as safety issue: No] - Measured by Clinical Opiate Withdrawal Scale (COWS), Desires for Drug Questionnaire (DDQ), and pupillometry.
Start Date
2011-01-01
Primary Endpoints Reported
2011-04-01
Patient Population
Subjects receivng stable Buprenorphine/Naloxone maintenance therapy.
Inclusion Criteria
Ages Eligible for Study: 18 Years to 64 Years Inclusion Criteria: - Males or females between the ages of 18 and 64 years, inclusive. Females must be of non-childbearing potential. - Receiving once daily buprenorphine/naloxone maintenance therapy at a stable dose not exceeding 24 mg/6 mg, respectively, for at least 2 weeks prior to screening.
Exclusion Criteria
Exclusion Criteria: - Illicit use of drugs such as cocaine, amphetamines and methylenedioxymethamphetamine (MDMA), barbiturates, benzodiazepines, tricyclic antidepressants, methadone or opiates/opioids (apart from buprenorphine). - Treatment with any investigational drug within the last 30 days, or 5 half-lives, whichever is longer. - Blood donation of 500 mL or more within the last 56 days. - Infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
Gender
Both
Age (Min)
18
Age (Min) Units
Years
Age (Max)
64
Age (Max) Units
Years
Prior/Concurrent Therapy
N/A
Target Accrual
16
Reported Sites
2
Identified Sites
0
Actual Accrual
N/A
Trial Locations
US
Treatment Plan
N/A
Study Keywords
N/A
Study Design
Study Type: Interventional Study Design: Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment This is a safety, drug-drug interaction study.
Investigators / Contacts
Scott McCallister, M.D.,Study Director/Responsible Party, Vertex Pharmaceuticals Incorporated Contact: 877-634-VRTX, Medical Information E-mail: medicalinfo@vrtx.com
Notes
Locations/Contacts Study Sites (Last Updated on June 7, 2011) [Last Accessed on June 10, 2011] United States, Kansas Overland Park, Kansas, United States United States, Utah Salt Lake City, Utah, United States http://www.clinicaltrials.gov/ct2/show/NCT01275599

Study Timing: Study Start Date: January 2011 Primary Completion Date: April 2011 (Final data collection date for primary outcome measure) http://www.clinicaltrials.gov/ct2/show/NCT01275599

April 28, 2011 Telaprevir 375-mg Film-Coated Tablet for the Treatment of Genotype 1 Chronic Hepatitis C Page#: 135 of 147 Proposed and On-Going Studies with Telaprevir Study Number: VX10-950-024 Purpose of study: The effect of telaprevir on the steady-state PK parameters of buprenorphine. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562.pdf
Supporting URLs
http://www.clinicaltrials.gov/ct2/show/NCT01275599
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562.pdf
Last Modified
2011-06-10
Last Full Review
2011-06-10
Internal Comments
N/A
Record URL
http://jnj.citeline.com/xt_view.asp?trialid=143219&target=10
Record Number
143219
Drug Name(s)
buprenorphine + naloxone
telaprevir

© 2002-2011 Citeline Inc. All rights reserved. This information is subject to a TrialTrove license agreement. See www.citeline.com/subscriptionlicense.html.

5.3 Adis Clinical Trials Database

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A Phase 1, Open-Label, Single-Sequence Study to Examine the Effect of Telaprevir on the Pharmacokinetics of Buprenorphine in Subjects on Stable Buprenorphine/Naloxone Maintenance Therapy.
700193621


Study Details
Purpose
This trial will investigate the effect of telaprevir on the pharmacokinetics of buprenorphine in patients receiving stable buprenorphine/Naloxone maintenance therapy. The primary outcomes are area under the drug concentration time curve, time to peak drug concentration, trough drug concentration, peak drug concentration. These will be assessed at day -4 through day 38 and day -1 and day 7.
Start Date: 01 Jan 2011 (actual)
End Date: 01 Apr 2011 (actual)

Details Study Design: multicentre, open, prospective
Study Controls: baseline comparison
Study Status: Completed
Study Phase: I
Study Location: USA
Study Endpoint: Area under the drug concentration time curve, Assessment scale scores, Peak drug concentration, Symptoms, Time to peak drug concentration, Trough drug concentration

Subjects Type: patients
Number: 16
Age: 18-64 years, adult

Patient Inclusion: Males or females between the ages of 18 and 64 years, inclusive. Females must be of non-childbearing potential. - Receiving once daily buprenorphine/naloxone maintenance therapy at a stable dose not exceeding 24 mg/6 mg, respectively, for at least 2 weeks prior to screening.
Patient Exclusion: Illicit use of drugs such as cocaine, amphetamines and methylenedioxymethamphetamine (MDMA), barbiturates, benzodiazepines, tricyclic antidepressants, methadone or opiates/opioids (apart from buprenorphine). - Treatment with any investigational drug within the last 30 days, or 5 half-lives, whichever is longer. - Blood donation of 500 mL or more within the last 56 days. - Infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).

Study Centre Details
NameCountryInvestigatorsContact Details
ibotec BVBA  
Overland ParkUSA 
Salt Lake CityUSA 
Vertex Pharmaceuticals Scott McCallister, M.D.877-634-VRTXE-mail: medicalinfo@vrtx.com

Study Status History
DateEventCommentUpdate Date
11/06/2011Other trial eventProfile reviewed.11/06/2011
07/06/2011Other trial eventLast checked against ClinicalTrials.gov record.11/06/2011
07/06/2011Status change - completedStatus changed from recruiting to completed as reported by ClinicalTrials.gov.11/06/2011
21/01/2011New trial recordNew trial record21/01/2011

Disease Treated
IndicationPatient Segment
Hepatitis-C 

Treatments
NameDoseRouteFreqDur.
Buprenorphine/naloxone24/6 mg/doseSLd14-38
Telaprevir2250 mg/dayPOq8h d1-7 


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6.1 ClinicalTrials.Gov

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Trial Identifier
2010-023287-41
ANRS HC26 TelapreVIH
NCT01332955
Trial Title
Telaprevir In HIV-HCV Coinfected Patients Who Had Previously Failed A Peginterferon-Ribavirin Regimen
Acronym
ANRSHC26
Original Title
Pilot Study of PegInterferon-Ribavirin-Telaprevir Efficacy and Tolerability in HIV-HCV Coinfected Patients Who Had Previously Failed a PegInterferon-Ribavirin Regimen. (ANRS HC26 TelapreVIH)
Sponsor(s)
French National Agency for Research on AIDS and Viral Hepatitis
Janssen-Cilag Ltd.
Source
French National Agency for Research on AIDS and Viral Hepatitis
Oversight
France: Afssaps - French Health Products Safety Agency
Brief Summary
This phase II, multicentric, national pilot trial is designed to estimate the sustained virological response rate (SVR) following a 12 weeks treatment by telaprevir combined with a 48 or 72 weeks treatment by peginterferon and ribavirin, based upon the rapid virological response (RVR) at week 8 (4 weeks after telaprevir start), and to compare the observed SVR to 20%, a rate determining a significant therapeutic benefit in this population of patients.
Detailed Description
This phase II pilot trial is designed for HIV-1 and HCV genotype 1 coinfected patients who had previously failed a peginterferon-ribavirin regimen.

Intervention Design:

- Induction, Lead-in, phase: day 0 to week 4 PegInterferon alpha-2a, 180 µg subcutaneous injection, once weekly + Ribavirin (weight-based dose) 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d.

- Telaprevir phase: week 4 to week 16 PegInterferon alpha-2a, 180 µg subcutaneous injection, once weekly + Ribavirin (weight-based dose) 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d.

+ Telaprevir 750 mg q 8h (or 1125 mg q 8h in association with Efavirenz)

- Maintenance phase: week 16 to week 48 or 72 PegInterferon alpha-2a, 180 µg subcutaneous injection, once weekly + Ribavirin (weight-based dose) 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d.

The duration of the maintenance phase is determined by the RVR at week 8 (4 weeks after Telaprevir start.

Complete RVR (undetectable HCV-RNA at week 8): maintenance from week 16 to week 48

_Partial RVR (HCV-RNA below 1 000 UI/mL but still detectable at week 8): maintenance phase from week 16 to week 48

And stable antiretroviral treatment for over 3 months among the authorized combinations: (tenofovir 300 mg, emtricitabine 200 mg, atazanavir 300 mg, ritonavir 100 mg) q.d. or (tenofovir 300 mg, emtricitabine 200 mg, efavirenz 600 mg) q.d. or (tenofovir 300 mg, emtricitabine 200 mg q.d. and raltegravir 400 mg b.i.d.) once Drug-Drug interaction data will be available. Patients who could not receive one of these 3 combinations can be included if they are receiving a stable combination of at least 3 drugs among the following: tenofovir, emtricitabine/lamivudine, efavirenz, atazanavir-boosted or not, raltegravir (once Drug-Drug interaction data will be available). These patients cannot participate in the pharmacokinetic study.

The trial will enroll 80 subjects. The proportion of patients included, presenting with cirrhosis (METAVIR F4) will remain below 50% of all patients The proportion of patients included, null-responders to previous HCV treatment (HCV-RNA decline at week 12 less than 2 log10 UI/ml) but no cirrhosis (maximum equal METAVIR F3) will remain below 30% of patients.
Overall Status
Recruiting
Start Date
April 2011
Completion Date
January 2014 (Anticipated)
Phase
Phase 2
Study Type
Interventional
Study Design
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
# Arms
1
Enrollment
80 (Anticipated)
Eligibility Criteria
Inclusion Criteria:

- Informed consent form signed at screening visit at the latest

- Patient registered with or covered by a social security scheme

- HIV-1 infection

- Chronic, genotype 1, hepatitis C with detectable HCV RNA at screening

- Virological failure following a previous treatment of at least 12 weeks by peginterferon alpha-2a ≥ 135 µg once weekly or peginterferon alpha-2b ≥ 1.0 µg per kg once weekly + ribavirin ≥ 600 mg once daily. Virological failure defined by persistence of a detectable HCV-RNA, with the same genotype than before. Null responder patient, with less than 2 Log10 HCV-RNA decline at week 12 with cirrhosis are excluded from the study. Null responder patients without cirrhosis (equal or below METAVIR F3) are limited to less than 30 % of all patients included

- No Interferon and/or Ribavirin within past 6 months

- Stable antiretroviral treatment for over 3 months at screening. Authorized combinations: tenofovir-emtricitabine-boosted atazanavir,tenofovir-emtricitabine-efavirenz,tenofovir-emtricitabine-raltegravir, once Drug-Drug interaction data will be available. Patients with a stable combination of at least 3 of the following drugs: tenofovir, emtricitabine/lamivudine, efavirenz, atazanavir-boosted or not, raltegravir. These patients cannot participate in the pharmacokinetic study

- CD4 >200/mm3 and >15% at screening

- Plasma HIV-RNA <50 copies/mL for at least 6 months at screening visit

- Body weight ≥ 40 kg to equal or below 125 kg

- Fibrosis stage have to be documented by a significant liver biopsy (cumulative length ≥ 15 mm or ≥ 6 portal spaces), within 3 years. Patients with a previous liver biopsy exhibiting cirrhosis lesions (METAVIR F4) are allowed to enter the study without a new biopsy. The proportion of patients with cirrhosis lesions (METAVIR F4) is limited to 50% of all patients.

- Male patients, female patients with child-bearing potency and their heterosexual partners must use an adequate contraception from 1 month before initiation of treatment to 7 months following the end of treatment for men and to 4 months following the end of treatment for women. Subjects (or their female partners) must not be pregnant or planning to become pregnant within 2 years after enrolling in the study

Exclusion Criteria:

- Patient with liver failure (Child B and C) or past history of decompensated cirrhosis

- Significant oesophageal varices (Stages 2-3) on a gastrointestinal endoscopy within 3 years

- Detectable AgHBs

- HIV-2 co-infection

- Contra-indication to ribavirin or peginterferon

- Severe pre-existing cardiac or pulmonary disease

- Untreated dysthyroidism

- Uncontrolled Type 2 diabetes

- Optic neuritis past history and retinal condition

- History of organ transplant

- Severe hemoglobinopathy

- Congenital QT prolongation, family history of congenital QT prolongation or sudden unexpected death

- Contra-indication to telaprevir, hypersensitivity to any component of the drug product

- Any disease requiring long term, systemic corticotherapy or immunosuppressive therapy during study

- Alcohol intake that may represent an obstacle for the participation of the subject

- Substance abuse that may represent an obstacle for the participation of the subject

- Acute CDC stage C opportunistic infection within the previous 6 months

- Past history of cancer within the previous 5 years (except skin basal cell carcinoma, Kaposi's disease in stable remission, in situ cervical cancer and in situ anal cancer)

- Any active malignant disease including hepatocellular carcinoma

- Patients unable to observe the study procedures

- Participation to another clinical trial within the previous 30 days

- Haemoglobin <120 g/L for women and <130 g/L for men

- Platelets <90 000/mm3

- Neutrophils <1 500/mm3

- Renal insufficiency defined by an estimated Glomerular Filtration Rate < 60 mL/mn (MDRD equation)

- Associated medication susceptible to interfere with the pharmacokinetic parameters of telaprevir and/or antiretroviral associated drugs
Gender
Both
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers?
No
Countries
France
Supporting Links
http://www.anrs.fr
Last Changed Date
2011-05-18
Interventions
NameTypeDescriptionGroup
TelaprevirDrugDrug : telaprevir, Tablet, Oral, 750 mg, q8h, 12 weeks if associated with atazanavir or raltegravir (++)telaprevir
peginterferon alfa-2aBiologicalSubcutaneous injection, 180 μg, once weekly, 48 weeks or 72 weekstelaprevir
RibavirinDrug(weight-based dose) Tablet, Oral, 1000 mg for subjects weighing below 75 kg or 1200 mg for subjects weighing equal or over75 kg, once daily, 48 weeks or 72 weekstelaprevir
Drugs
Telaprevir
Ribavirin
Primary Outcome
Estimation of SVR following a 12 wks treatment by telaprevir combined with a 48 or 72 wks peginterferon-ribavirin treatment, based upon the rapid virological response, and comparison to 20% (which would correspond to a significant therapeutic benefit)
Secondary Outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Safety Issue]
Condition
Hepatitis C, Chronic
HIV Infection
Overall Official
Tibotec Pharmaceuticals Clinical Trial
Study Director
Tibotec Pharmaceutical Limited
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Laurent COTTE, MD
Principal Investigator
Hopital Croix Rousse LYON FRANCE
Jean-Pierre ABOULKER, MD
Study Chair
INSERM SC10 VILLEJUIF FRANCE
Num. Locations
1
Num. Recruiting
1

Information obtained from ClinicalTrials.gov on September 11, 2011

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Trial Title
Pilot Study of PegInterferon-Ribavirin-Telaprevir Efficacy and Tolerability in HIV-HCV Coinfected Patients Who Had Previously Failed a PegInterferon-Ribavirin Regimen. (ANRS HC26 TelapreVIH).
Disease Type
HCV
HIV
Trial Phase
II
Patient Segment
Chronic hepatitis C
Genotype 1
Other comorbidity
Treatment experienced
Sponsorship
Agency of AIDS Research in France (ANRS)
French National Agency for Research on AIDS and Viral Hepatitis
Johnson & Johnson/Janssen-Cilag
Primary Drugs
telaprevir
Other Drugs
atazanavir sulfate (capsule)
efavirenz
Emtricitabine
lamivudine
peginterferon alfa-2a (SC)
raltegravir (tablet)
ribavirin (oral)
ribavirin, Roche
ritonavir, soft gel
tenofovir
Trial Identifier
ANRS HC26
ANRS HC26 TelapreVIH
ANRSHC26
EudraCT No: 2010-023287-41
NCT01332955
TrialTroveID-142607
Trial Status
Open
Trial Objectives
To evaluate the efficacy of combination therapy peginterferon-Ribavirin-telaprevir in patients co-infected HIV-HCV, in a failed previous treatment with peginterferon and ribavirin. To estimate the sustained virological response rate (SVR) following a 12 weeks treatment by telaprevir combined with a 48 or 72 weeks treatment by peginterferon and ribavirin, based upon the rapid virological response (RVR) at week 8 (4 weeks after telaprevir start). To compare the observed SVR to 20%, a rate determining a significant therapeutic benefit in this population of patients.
Primary Endpoints
Primary Objective: - The main objective of this study is to estimate, in patients co-infected HIV / HCV genotype 1 after a failure previous treatment with peginterferon and ribavirin combination therapy, the rate of sustained virologic response (SVR) obtained after 12-week treatment with telaprevir, peginterferon and ribavirin combination for 48 to 72 weeks depending on response. - Rapid virological S8, and compare it to 21% rate at which it shall be a therapeutic advance significant for this patient population. Primary Outcome Measures: Estimation of SVR following a 12 wks treatment by telaprevir combined with a 48 or 72 wks peginterferon-ribavirin treatment, based upon the rapid virological response, and comparison to 20% (which would correspond to a significant therapeutic benefit) [ Time Frame: up to 92 weeks or 116 weeks depending on rapid virologic response ] [ Designated as safety issue: No ]
Other Endpoints
Secondary objectives - Evaluation of tolerance and perceived symptoms - Rating HCV and HIV virological - Pharmacological evaluation - Rating liver and metabolic - Studies of Pharmacogenetics Secondary Outcome Measures: Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: From week 0 up to 92 weeks or 116 weeks depending on rapid virologic response ] [ Designated as safety issue: Yes ]
Start Date
2011-04-01
Primary Endpoints Reported
2014-01-01
Patient Population
HIV-HCV coinfected patients.
Inclusion Criteria
Ages Eligible for Study: 18 Years and older Inclusion Criteria: - Informed consent form signed at screening visit at the latest - Patient registered with or covered by a social security scheme - HIV-1 infection - Chronic, genotype 1, hepatitis C with detectable HCV RNA at screening - Virological failure following a previous treatment of at least 12 weeks by peginterferon alpha-2a > or = 135 mcg once weekly or peginterferon alpha-2b > or = 1.0 mcg per kg once weekly + ribavirin > or = 600 mg once daily. Virological failure defined by persistence of a detectable HCV-RNA, with the same genotype than before. Null responder patient, with less than 2 Log10 HCV-RNA decline at week 12 with cirrhosis are excluded from the study. Null responder patients without cirrhosis (equal or below METAVIR F3) are limited to less than 30 % of all patients included - No Interferon and/or Ribavirin within past 6 months - Stable antiretroviral treatment for over 3 months at screening. Authorized combinations: tenofovir-emtricitabine-boosted atazanavir,tenofovir-emtricitabine-efavirenz,tenofovir-emtricitabine-raltegravir, once Drug-Drug interaction data will be available. Patients with a stable combination of at least 3 of the following drugs: tenofovir, emtricitabine/lamivudine, efavirenz, atazanavir-boosted or not, raltegravir. These patients cannot participate in the pharmacokinetic study - CD4 >200/mm^3 and >15% at screening - Plasma HIV-RNA <50 copies/mL for at least 6 months at screening visit - Body weight > or = 40 kg to equal or below 125 kg - Fibrosis stage have to be documented by a significant liver biopsy (cumulative length > or = 15 mm or > or = 6 portal spaces), within 3 years. Patients with a previous liver biopsy exhibiting cirrhosis lesions (METAVIR F4) are allowed to enter the study without a new biopsy. The proportion of patients with cirrhosis lesions (METAVIR F4) is limited to 50% of all patients. - Male patients, female patients with child-bearing potency and their heterosexual partners must use an adequate contraception from 1 month before initiation of treatment to 7 months following the end of treatment for men and to 4 months following the end of treatment for women. Subjects (or their female partners) must not be pregnant or planning to become pregnant within 2 years after enrolling in the study
Exclusion Criteria
Exclusion Criteria: - Patient with liver failure (Child B and C) or past history of decompensated cirrhosis - Significant oesophageal varices (Stages 2-3) on a gastrointestinal endoscopy within 3 years - Detectable AgHBs - HIV-2 co-infection - Contra-indication to ribavirin or peginterferon - Severe pre-existing cardiac or pulmonary disease - Untreated dysthyroidism - Uncontrolled Type 2 diabetes - Optic neuritis past history and retinal condition - History of organ transplant - Severe hemoglobinopathy - Congenital QT prolongation, family history of congenital QT prolongation or sudden unexpected death - Contra-indication to telaprevir, hypersensitivity to any component of the drug product - Any disease requiring long term, systemic corticotherapy or immunosuppressive therapy during study - Alcohol intake that may represent an obstacle for the participation of the subject - Substance abuse that may represent an obstacle for the participation of the subject - Acute CDC stage C opportunistic infection within the previous 6 months - Past history of cancer within the previous 5 years (except skin basal cell carcinoma, Kaposi's disease in stable remission, in situ cervical cancer and in situ anal cancer) - Any active malignant disease including hepatocellular carcinoma - Patients unable to observe the study procedures - Participation to another clinical trial within the previous 30 days - Haemoglobin <120 g/L for women and <130 g/L for men - Platelets <90 000/mm^3 - Neutrophils <1 500/mm^3 - Renal insufficiency defined by an estimated Glomerular Filtration Rate < 60 mL/mn (MDRD equation) - Associated medication susceptible to interfere with the pharmacokinetic parameters of telaprevir and/or antiretroviral associated drugs
Gender
Both
Age (Min)
18
Age (Min) Units
Years
Age (Max) Units
Years
Prior/Concurrent Therapy
N/A
Target Accrual
80 (68 in France)
Reported Sites
1
Identified Sites
2
Actual Accrual
N/A
Trial Locations
France
Treatment Plan
N/A
Study Keywords
safety efficacy
Study Design
Study Type: Interventional Study Design: Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment This is a pharmacokinetic study. This is a multicentric, national, pilot study.
Investigators / Contacts
Jean-Pierre ABOULKER, MD, Study Chair, INSERM SC10 VILLEJUIF FRANCE Laurent COTTE, MD, Principal Investigator, Hopital Croix Rousse LYON FRANCE Phone: +33 4 26 73 26 56 E-mail: laurent.cotte@chu-lyon.fr Karim Kaabeche, Project manager/Responsible Party, French National Agency for Research on AIDS and Viral Hepatitis Contact: Joséphine BRAUN, PhD Phone: +33 1 45 59 60 69 E-mail: josephine.braun@inserm.fr
Notes
Locations/Contacts Study Site and Contact information (Last Updated on May 18, 2011) [Last accessed on August 10, 2011]: Contact: Laurent COTTE, MD +33 4 26 73 26 56 laurent.cotte@chu-lyon.fr Contact: Joséphine BRAUN, PhD +33 1 45 59 60 69 josephine.braun@inserm.fr France Services Maladies Infectieuses et Tropicales, Hôpital de la Croix-Rousse Recruiting LYON Cedex 04, France, 69317 Principal Investigator: Laurent COTTE, MD http://www.clinicaltrials.gov/ct2/show/NCT01332955

Study Timing: Study Start Date: April 2011 Estimated Study Completion Date: January 2014 Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure) http://www.clinicaltrials.gov/ct2/show/NCT01332955

[Translated from French] Excerpted from French Agency for the Safety of Health Products. [Accessed on May 20, 2011] Test Description: Full track Pilot study evaluating the efficacy of combination therapy peginterferon - Ribavirin-telaprevir in patients co-infected HIV-HCV, in a failed previous treatment with peginterferon and ribavirin Current status of trial: Not Started (More information about the trial) Disease (s) or condition (s) (s) concerned by the test This study aims at evaluating the efficacy and safety of peginterferon-ribavirin combination therapy-telaprevir in patients co-infected HIV / HCV genotype 1, failure of previous treatment with peginterferon and ribavirin Rare disease Yes No (View MedDRA codes) Tabular data available at the URL Persons undergoing testing Tranche (s) studied age (s) 18 to 65 years Sex Men Women (More information about the persons undergoing the test) Proponent Information Name: ANRS Status: noncommercial Address: 101, rue de Tolbiac Postal Code: 75013 City: Paris Country: Original Text: Description de l'essai Titre complet Etude pilote évaluant l'efficacité de la trithérapie PegInterféron - Ribavirine -Telaprévir chez des patients co-infectés VIH-VHC, en échec d'un traitement antérieur par PegInterféron et Ribavirine Etat d'avancement de l'essai : Non débuté (Plus d'informations sur l'essai) Maladie(s) ou affection(s) concernée(s) par l'essai Cette étude a pour objectif l'évaluation l'efficacité et la tolérance de la trithérapie PegInterféron-Ribavirine-Telaprévir chez des patients co-infectés VIH-VHC de génotype 1, en échec d'un traitement antérieur par PegInterféron et Ribavirine Maladie rare Oui Non (Voir les codes MedDRA) Tabular data available at the URL Personnes se prêtant à l'essai Tranche(s) d'âge étudiée(s) Moins de 18 ans De 18 à 65 ans Plus de 65 ans Sexe Hommes Femmes Plus d'informations sur les personnes se prêtant à l'essai Information sur le promoteur Nom : ANRS Statut : non commercial Adresse : 101, rue de Tolbiac Code Postal : 75013 Ville: Paris Pays : https://icrepec.afssaps.fr/Public/essai.php?num=2010-023287-41
Trial Tags
PGX - pathogen
Supporting URLs
http://mediatheque.lecrips.net/doc_num.php?explnum_id=33528
http://translate.google.co.in/translate?hl=en&sl=fr&u=http://mediatheque.lecrips.net/doc_num.php%3Fexplnum_id%3D33528&ei=YjXWTa_wIpLEsAP-uvC3Bw&sa=X&oi=translate&ct=result&resnum=4&ved=0CDIQ7gEwAw&prev=/search%3Fq%3D%2522ANRS%2BHC26%2522%2B%252B%2B%2522Telaprevir%2522%26hl%3Den%26safe%3Dactive%26client%3Dfirefox-a%26hs%3DMeh%26rlz%3D1R1GGHP_en___IN432%26prmd%3Divns
http://www.clinicaltrials.gov/ct2/show/NCT01332955
https://icrepec.afssaps.fr/Public/essai.php?num=2010-023287-41
Last Modified
2011-08-18
Last Full Review
2011-05-20
Internal Comments
N/A
Record URL
http://jnj.citeline.com/xt_view.asp?trialid=142607&target=10
Record Number
142607
Drug Name(s)
telaprevir
atazanavir sulfate (capsule)
efavirenz
Emtricitabine
lamivudine
peginterferon alfa-2a (SC)
raltegravir (tablet)
ribavirin (oral)
ribavirin, Roche
ritonavir, soft gel
tenofovir

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Pilot Study of PegInterferon-Ribavirin-Telaprevir Efficacy and Tolerability in HIV-HCV Coinfected Patients Who Had Previously Failed a PegInterferon-Ribavirin Regimen. (ANRS HC26 TelapreVIH)
700197330


Study Details
Purpose
This pilot trial aims to evaluate the efficacy and tolerability of second-line treatment with telaprevir + peginterferon alfa-2a + ribavirin in patients with HIV-1 infections who are co-infected with hepatitis C. The primary endpoint is the sustained virological response rate, with a significant therapeutic benefit of 20%. This will be evaluated at week 92 or week 116, depending on the duration of peginterferon alfa-2a + ribavirin treatment.
Start Date: 01 Apr 2011 (actual)
End Date: 01 Jan 2014 (planned)

Details Study Design: open, prospective
Study Controls: baseline comparison
Study Status: Recruiting
Study Phase: II
Study Location: France
Study Endpoint: Sustained virological response rate

Subjects Type: patients
Number: 80
Age: >= 18 years, adult, elderly

Patient Inclusion: Informed consent form signed at screening visit at the latest - Patient registered with or covered by a social security scheme - HIV-1 infection - Chronic, genotype 1, hepatitis C with detectable HCV RNA at screening - Virological failure following a previous treatment of at least 12 weeks by peginterferon alpha-2a >= 135 micrograms once weekly or peginterferon alpha-2b >= 1.0 micrograms per kg once weekly + ribavirin >= 600 mg once daily. Virological failure defined by persistence of a detectable HCV-RNA, with the same genotype than before. Null responder patient, with less than 2 Log10 HCV-RNA decline at week 12 with cirrhosis are excluded from the study. Null responder patients without cirrhosis (equal or below METAVIR F3) are limited to less than 30 % of all patients included - No Interferon and/or Ribavirin within past 6 months - Stable antiretroviral treatment for over 3 months at screening. Authorized combinations: tenofovir-emtricitabine-boosted atazanavir,tenofovir-emtricitabine-efavirenz,tenofovir-emtricitabine-raltegravir, once Drug-Drug interaction data will be available. Patients with a stable combination of at least 3 of the following drugs: tenofovir, emtricitabine/lamivudine, efavirenz, atazanavir-boosted or not, raltegravir. These patients cannot participate in the pharmacokinetic study - CD4 >200/mm3 and >15% at screening - Plasma HIV-RNA <50 copies/mL for at least 6 months at screening visit - Body weight >= 40 kg to equal or below 125 kg - Fibrosis stage have to be documented by a significant liver biopsy (cumulative length >= 15 mm or >= 6 portal spaces), within 3 years. Patients with a previous liver biopsy exhibiting cirrhosis lesions (METAVIR F4) are allowed to enter the study without a new biopsy. The proportion of patients with cirrhosis lesions (METAVIR F4) is limited to 50% of all patients. - Male patients, female patients with child-bearing potency and their heterosexual partners must use an adequate contraception from 1 month before initiation of treatment to 7 months following the end of treatment for men and to 4 months following the end of treatment for women. Subjects (or their female partners) must not be pregnant or planning to become pregnant within 2 years after enrolling in the study.
Patient Exclusion: Patient with liver failure (Child B and C) or past history of decompensated cirrhosis - Significant oesophageal varices (Stages 2-3) on a gastrointestinal endoscopy within 3 years - Detectable AgHBs - HIV-2 co-infection - Contra-indication to ribavirin or peginterferon - Severe pre-existing cardiac or pulmonary disease - Untreated dysthyroidism - Uncontrolled Type 2 diabetes - Optic neuritis past history and retinal condition - History of organ transplant - Severe hemoglobinopathy - Congenital QT prolongation, family history of congenital QT prolongation or sudden unexpected death - Contra-indication to telaprevir, hypersensitivity to any component of the drug product - Any disease requiring long term, systemic corticotherapy or immunosuppressive therapy during study - Alcohol intake that may represent an obstacle for the participation of the subject - Substance abuse that may represent an obstacle for the participation of the subject - Acute CDC stage C opportunistic infection within the previous 6 months - Past history of cancer within the previous 5 years (except skin basal cell carcinoma, Kaposi's disease in stable remission, in situ cervical cancer and in situ anal cancer) - Any active malignant disease including hepatocellular carcinoma - Patients unable to observe the study procedures - Participation to another clinical trial within the previous 30 days - Haemoglobin <120 g/L for women and <130 g/L for men - Platelets <90 000/mm3 - Neutrophils <1 500/mm3 - Renal insufficiency defined by an estimated Glomerular Filtration Rate < 60 mL/mn (MDRD equation) - Associated medication susceptible to interfere with the pharmacokinetic parameters of telaprevir and/or antiretroviral associated drugs.

Study Centre Details
NameCountryInvestigatorsContact Details
French National Agency for Research on AIDS and Viral HepatitisFranceKarim Kaabeche
Hopital de la Croix-Rousse, LyonFranceCotte LPhone: +33 4 26 73 26 56E-mail: Email: laurent.cotte@chu-lyon.fr
INSERM SC10, VillejuifFranceAboulker J-P,Braun JPhone: +33 1 45 59 60 69E-mail: Email: josephine.braun@inserm.fr
Janssen-Cilag Ltd.   

Study Status History
DateEventCommentUpdate Date
23/05/2011Other trial eventProfile reviewed.23/05/2011
18/05/2011Other trial eventLast checked against ClinicalTrials.gov record.23/05/2011
18/05/2011Status change - recruitingStatus changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov.23/05/2011
28/03/2011New trial recordNew trial record13/04/2011

Disease Treated
IndicationPatient Segment
Hepatitis-Cchronic
Hepatitis-Ccomorbid HIV infections
Hepatitis-Cgenotype 1
Hepatitis-Csecond-line-or-greater therapy
HIV-1-infectionscomorbid hepatitis C
HIV-1-infectionssecond-line-or-greater therapy

Treatments
NameDoseRouteFreqDur.
Peginterferon alfa-2a180 µg/doseSC inj1/week48 or 72 weeks
Ribavirin1000 or 1200 mg/dayPO 48 or 72 weeks
Telaprevir2250 or 3375 mg/dayPOq8h w4-1612 weeks


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Trial Identifier
CR017989
TMC125IFD1001
NCT01336829
Trial Title
TMC125IFD1001 - Drug-Drug Interaction of Etravirine With Telaprevir and TMC278 With Telaprevir.
Original Title
A Phase I, Open Label, Randomized, 2-Panel, 2-Way Crossover Trial to Investigate the Pharmacokinetic Interaction Between Etravirine or TMC278 and Telaprevir at Steady-State in Healthy Subjects.
Sponsor(s)
Tibotec Pharmaceuticals, Ireland
Source
Tibotec Pharmaceuticals, Ireland
Oversight
Ireland: Irish Agriculture and Food Development Authority
Brief Summary
The purpose of this study is to see the effect of etravirine or TMC278 on how telaprevir is absorbed into the body and the effect of telaprevir on how etravirine or TMC278 are absorbed into the body when administered together.
Detailed Description
This is an open-label, randomized, single-dose, crossover trial in healthy volunteers. Crossover means that participants may receive different interventions sequentially during the trial. Randomized means that you will be assigned to a treatment sequence by chance, like flipping a coin. Open-label means that you and your physician will know what treatment you will receive. The study will consist of 3 phases: a screening phase, a treatment phase and a follow-up phase. Total study duration for an individual participant will be approximately 11 weeks. Once found eligible after the screening phase, participants will take part in one of the two parts of the treatment phase. In the first part, a group of 16 participants will receive two treatment sessions, A and B. The order in which the treatments are given will be determined by chance. In treatment A, 200 mg (2 tablets) ETR (etravirine) will be given twice a day from day 1 to 10 with a morning dose only on day 11. In treatment B, 750 mg (2 tablets) TVR (telaprevir) will be given from day 1 to 17 every 8 hours with a morning and afternoon dose only on day 18 and 200 mg ETR will be given twice a day from day 8 to 17 with a morning dose on day 18. In between the 2 sessions, there will be at least 14 days. In the second part, another group of 16 participants will receive 2 treatment sessions, C and D. The order in which these treatments are given will be determined by chance. In treatment C, 25 mg (1 tablet) TMC278 will be given once a day from day 1 to 11. In treatment D, 750 mg (2 tablets) TVR (telaprevir) will be given from day 1 to 18 every 8 hours and 25 mg TMC278 will be given once a day from day 8 to 18. In between the 2 sessions, there will be at least 14 days. All treatments will be taken food. In treatments A and C, participants will come to the unit the day before dosing and in the mornings of day 1, 9 and 10 and for a whole day on day 11. Only in treatment C, overnight stay from day 11 to day 12 is foreseen. In treatment B, participants will come to the unit the day before dosing and in the mornings of days 1, 5, 6, 8, 16 and 17 and for a whole day on days 7 and 18. In treatment D, participants will come to the unit the day before dosing and in the mornings of days 1, 5, 6, 8, 12, 16 and 17 and for a whole day on days 7 and 18 with overnight stay from day 18 to 19. Five to 7 days after last dosing, participants will have a last follow-up visit at the unit (follow-up phase). During the study, safety will be monitored, and during the treatment phase, at specified timepoints, blood samples will be taken for pharmacokinetic evalutions (effect of the body on the drugs). In treatment A, 2 tablets ETR will be given twice a day from day 1 to 10 with a morning dose on day 11. In treatment B, 2 tablets TVR will be given every 8 hours from day 1 to17 with only 2 doses on day 18 and 2 tablets ETR twice a day from day 8 to 17 with a morning dose only on day 18. In treatment C, 1 tablet TMC278 will be given oncy a day from day 1 to 11. In treatment D, 2 tablets of TVR will be given every 8 hours from day 1 to 18 and 1 tablet TMC278 once a day from day 8 to 18.
Overall Status
Active, not recruiting
Start Date
April 2011
Completion Date
August 2011 (Anticipated)
Phase
Phase 1
Study Type
Interventional
Study Design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
# Arms
4
Enrollment
33 (Actual)
Eligibility Criteria
Inclusion Criteria:

- Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection

- A Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2

- Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests performed at Screening

- Women must be postmenopausal for at least 2 years or be surgically sterile or be not heterosexually active for the duration of the study, or have a vasectomized partner, or if of childbearing potential and heterosexually active, be practicing a highly effective method of birth control.

Exclusion Criteria:

- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures

- A positive urine drug test at Screening

- Use of disallowed therapies: concomitant medication, including over-the-counter products, herbal preparations and dietary supplements

- History of significant drug allergy

- Received an investigational drug or used an investigational medical device within 60 days preceding the first intake of study medication or having previously participated in a study with either ETR, TMC278, telaprevir.
Gender
Both
Minimum Age
18 Years
Maximum Age
55 Years
Healthy Volunteers?
Accepts Healthy Volunteers
Last Changed Date
2011-07-14
Interventions
NameTypeDescriptionGroup
telaprevir/ETRDrugTreatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18, and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18.002
ETR/telaprevirDrugTreatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18, and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18.001
telaprevir/TMC278DrugTreatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18, and TMC278 25 mg once daily from Day 8 to Day 18.004
TMC278/telaprevirDrugTreatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18, and TMC278 25 mg once daily from Day 8 to Day 18.003
Drugs
telaprevir/ETR
ETR/telaprevir
telaprevir/TMC278
TMC278/telaprevir
Primary Outcome
Bloodlevels of telaprevir following co-administration with ETR
Bloodlevels of telaprevir following co-administration with TMC278
Bloodlevels of ETR following co-administration with telaprevir
Bloodlevels of TMC278 following co-administration with telaprevir
Secondary Outcome
Observed values and changes from baseline for abnormal values of laboratory results. [Safety Issue]
Observed values and changes from baseline for electrocardiograms (interpretation of electrical activity of the heart) [Safety Issue]
Evaluation of pulse and blood pressure values, based on changes from baseline and the percentage of participants with values beyond clinically important limits [Safety Issue]
Physical examination findings and changes from baseline. [Safety Issue]
Number of participants with adverse events and the severity of adverse events [Safety Issue]
Bloodlevels of ETR in function of variations of 2 genes (CYP2C9 and CYP2C19)
Condition
Hepatitis C
HIV
Overall Official
Tibotec Pharmaceuticals Clinical Trial
Study Director
Tibotec Pharmaceutical Limited
Num. Locations
0
Num. Recruiting
0

Information obtained from ClinicalTrials.gov on September 11, 2011

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Trial Title
A Phase I, Open Label, Randomized, 2-Panel, 2-Way Crossover Trial to Investigate the Pharmacokinetic Interaction Between Etravirine or TMC278 and Telaprevir at Steady-State in Healthy Subjects.
Disease Type
HCV
HIV
Trial Phase
I
Patient Segment
(N/A)
Sponsorship
Johnson & Johnson/Janssen Biotech/Tibotec {J&J/Centocor Ortho Biotech/Tibotec Therapeutics {J&J/Ortho Biotech/Tibotec}}
Primary Drugs
etravirine (tablet)
rilpivirine
telaprevir
Trial Identifier
CR017989
NCT01336829
TMC125IFD1001
TrialTroveID-145237
Trial Status
Closed
Trial Objectives
To assess the effect of etravirine or TMC278 on how telaprevir is absorbed into the body and the effect of telaprevir on how etravirine or TMC278 are absorbed into the body when administered together.
Primary Endpoints
Primary Outcome Measures: - Bloodlevels of telaprevir following co-administration with ETR [ Time Frame: Over 8 hours on day 18 of treatment B. ] [ Designated as safety issue: No ] - Bloodlevels of telaprevir following co-administration with TMC278 [ Time Frame: Over 8 hours on day 18 of treatment B. ] [ Designated as safety issue: No ] - Bloodlevels of ETR following co-administration with telaprevir [ Time Frame: Over 12 hours on day 18 of treatment B. ] [ Designated as safety issue: No ] - Bloodlevels of TMC278 following co-administration with telaprevir [ Time Frame: Over 24 hours on day 18 of treatment D ] [ Designated as safety issue: No ]
Other Endpoints
Secondary Outcome Measures: - Bloodlevels of ETR in function of variations of 2 genes (CYP2C9 and CYP2C19) [ Time Frame: 1 bloodsample on day 1 of treatment A. ] [ Designated as safety issue: No ] - Number of participants with adverse events and the severity of adverse events [ Time Frame: Over approximately 11 weeks ] [ Designated as safety issue: Yes ] - Evaluation of pulse and blood pressure values, based on changes from baseline and the percentage of participants with values beyond clinically important limits [ Time Frame: Over approximately 11 weeks ] [ Designated as safety issue: Yes ] - Physical examination findings and changes from baseline. [ Time Frame: Over approximately 11 weeks ] [ Designated as safety issue: Yes ] - Observed values and changes from baseline for abnormal values of laboratory results. [ Time Frame: Over approximately 11 weeks ] [ Designated as safety issue: Yes ] - Observed values and changes from baseline for electrocardiograms (interpretation of electrical activity of the heart) [ Time Frame: Over approximately 11 weeks ] [ Designated as safety issue: Yes ]
Start Date
2011-04-01
Patient Population
Healthy subjects.
Inclusion Criteria
Ages Eligible for Study: 18 Years to 55 Years Inclusion Criteria: - Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection. - A Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m^2. - Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests performed at Screening. - Women must be postmenopausal for at least 2 years or be surgically sterile or be not heterosexually active for the duration of the study, or have a vasectomized partner, or if of childbearing potential and heterosexually active, be practicing a highly effective method of birth control.
Exclusion Criteria
Exclusion Criteria: - History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures. - A positive urine drug test at Screening. - Use of disallowed therapies: concomitant medication, including over-the-counter products, herbal preparations and dietary supplements. - History of significant drug allergy. - Received an investigational drug or used an investigational medical device within 60 days preceding the first intake of study medication or having previously participated in a study with either ETR, TMC278, telaprevir.
Gender
Both
Age (Min)
18
Age (Min) Units
Years
Age (Max)
55
Age (Max) Units
Years
Prior/Concurrent Therapy
N/A
Target Accrual
32
Reported Sites
1
Identified Sites
0
Actual Accrual
33
Trial Locations
Belgium
Treatment Plan
N/A
Study Keywords
N/A
Study Design
Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment This is a 2-Panel, single-dose, drug-drug interaction study.
Investigators / Contacts
Tibotec Pharmaceuticals Clinical Trial, Study Director/Responsible Party, Tibotec Pharmaceuticals, Ireland (Compound Development Team Leader)
Notes
The projected primary completion date was removed because that date passed without evidence of completion of primary endpoints. August 2011 http://www.clinicaltrials.gov/ct2/show/NCT01336829

Study Timing Study Start Date: April 2011 Estimated Study Completion Date: August 2011 Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure) http://www.clinicaltrials.gov/ct2/show/NCT01336829

Locations/Contacts Study SIte and Contact information (Last Updated: June 23, 2011) [Last Accessed on June 27, 2011] Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: info1@veritasmedicine.com Belgium Recruiting Antwerp, Belgium [The content of this URL has changed] http://www.clinicaltrials.gov/ct2/show/NCT01336829
Trial Tags
PGX
Supporting URLs
http://www.clinicaltrials.gov/ct2/show/NCT01336829
Last Modified
2011-09-09
Last Full Review
2011-07-16
Internal Comments
N/A
Record URL
http://jnj.citeline.com/xt_view.asp?trialid=145237&target=10
Record Number
145237
Drug Name(s)
etravirine (tablet)
rilpivirine
telaprevir

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A Phase I, Open Label, Randomized, 2-Panel, 2-Way Crossover Trial to Investigate the Pharmacokinetic Interaction Between Etravirine or TMC278 and Telaprevir at Steady-State in Healthy Subjects.
700197698


Study Details
Purpose
This study will investigate the pharmacokinetic interaction between etravirine or rilpivirine [TMC-278] and telaprevir at steady-state in volunteers. The primary endpoints are blood levels of telaprevir, etravirine, and rilpivirine following co-administration.
Start Date: 01 Apr 2011 (actual)
End Date: 01 Aug 2011 (planned)

Details Study Design: crossover, open, prospective, randomised
Study Controls: drug combination comparison
Study Status: Active, no longer recruiting
Study Phase: I
Study Location: Belgium Ireland Multinational
Study Endpoint: Drug concentration

Subjects Type: volunteers
Number: 33
Age: 18-55 years, adult

Patient Inclusion: Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection - A Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2 - Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests performed at Screening - Women must be postmenopausal for at least 2 years or be surgically sterile or be not heterosexually active for the duration of the study, or have a vasectomized partner, or if of childbearing potential and heterosexually active, be practicing a highly effective method of birth control.
Patient Exclusion: History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator&apos;s opinion would compromise the participant&apos;s safety and/or compliance with the study procedures - A positive urine drug test at Screening - Use of disallowed therapies: concomitant medication, including over-the-counter products, herbal preparations and dietary supplements - History of significant drug allergy - Received an investigational drug or used an investigational medical device within 60 days preceding the first intake of study medication or having previously participated in a study with either ETR, TMC278, telaprevir.

Study Centre Details
NameCountryInvestigatorsContact Details
   E-mail: info1@veritasmedicine.com
AntwerpBelgium 
Tibotec Pharmaceutical Limited  
Tibotec Pharmaceuticals, Ireland   

Study Status History
DateEventCommentUpdate Date
19/07/2011Other trial eventProfile reviewed.19/07/2011
14/07/2011Other trial eventLast checked against ClinicalTrials.gov record.19/07/2011
14/07/2011Status change - active, no longer recruitingStatus changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.19/07/2011
21/04/2011New trial recordNew trial record21/04/2011

Disease Treated
IndicationPatient Segment
Hepatitis-C
HIV-infections 

Treatments
NameDoseRouteFreqDur.
Etravirine200-400 mg/dayPObid d8-17 then od d1811 days
Etravirine400 then 200 mg/dayPObid d1-10 then od d1111 days
Rilpivirine25 mg/dayPOod d1-1111 days
Rilpivirine25 mg/dayPOod d8-1811 days
Telaprevir2250 mg/dayPOtid d1-17 then bid d1811 days
Telaprevir2250 mg/dayPOtid d1-1811 days


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Trial Identifier
M11-219
NCT01415141
Trial Title
Peginterferon and Ribavirin, With or Without Telaprevir, for Genotype 1 Hepatitis C and IL28B CC Polymorphism
Original Title
A Randomized Trial of Telaprevir, Peginterferon, and Ribavirin Versus Peginterferon and Ribavirin for Treatment of Genotype 1 Hepatitis C Virus With Host Interleukin 28B CC Polymorphism
Sponsor(s)
University of Vermont
Source
University of Vermont
Oversight
United States: Institutional Review Board
Brief Summary
Chronic hepatitis C is a major cause of liver disease and is thus an important public health problem. Although some strains (genotypes) of the hepatitis C virus are highly responsive to treatment with a combination of peginterferon and ribavirin, the most common form of the virus (genotype 1) is relatively resistant to this treatment. Recently, telaprevir has been approved by the Food and Drug Administration to be given in combination with peginterferon and ribavirin. This 3-drug combination boosts the remission rate for genotype 1 hepatitis C to that seen with other more responsive hepatitis C genotypes treated with only peginterferon and ribavirin. However, telaprevir has additional side affects such as rash and anemia that may limit its usefulness. Intriguingly, about one third of patients infected with genotype 1 hepatitis C, who have a specific variation (polymorphism) in the DNA sequence (CC) near an immune response gene (IL28B), in fact are highly responsive to 2-drug treatment with peginterferon and ribavirin. This raises the possibility that individuals who have the IL28B CC polymorphism may not need to be treated with the addition of telaprevir and could therefore be spared unnecessary side effects. Thus, the purpose of this study is to determine among genotype 1 hepatitis C patients with the IL28B CC polymorphism the success rate and side effects of 3-drug treatment compared with 2-drug treatment.

In this study, patients with genotype 1 chronic hepatitis C who have the IL28B CC polymorphism will be randomly assigned to be treated with telaprevir, peginterferon, and ribavirin or with only peginterferon with ribavirin. These medications and the procedures involved, including patient history, physical examination, and obtaining small volume blood specimens (less than 4 teaspoons) for laboratory testing, are within the scope of standard management of hepatitis C treatment. All patients will be monitored during treatment with periodic blood testing (weeks 2, 4, and every 4 weeks thereafter while on treatment, and 24 weeks after stopping treatment) and office visits (weeks 5, 12, 25, 49 while on treatment and 25 weeks after stopping treatment). The success of treatment will be judged by the presence or absence of detectable virus in blood, as measured by a sensitive diagnostic test (PCR). The data to be generated will include measurement by PCR of hepatitis C viral loads before, during, and after treatment, as well as reporting of adverse drug effects.
Detailed Description
Chronic infection with the hepatitis C virus (HCV), which affects 1-2% of adults in the United States, is a major risk factor for liver failure due to cirrhosis and/or hepatocellular carcinoma (Davis 2010). Epidemiological information suggests that the frequency of these HCV-related sequelae is likely to continue to increase over the next 10-15 years unless effective and well-tolerated treatments become available. Development of improved antiviral therapy is thus an important public health priority.

Until recently, the most effective treatment for chronic HCV infection has been a combination of peginterferon and ribavirin, given for up to 48 weeks. With this regimen, the sustained virological response (SVR), defined as undetectable HCV RNA 24 weeks after completion of antiviral treatment, is approximately 50-60% (Hoofnagle 2006). Not all patients are able to complete therapy however; up to 10% will discontinue this prematurely as a result of intolerable side effects, predominantly depression and/or fatigue (Seeff 2010). The major determinants of responsiveness to antiviral therapy are viral genotype and selected host characteristics. Hepatitis C genotype 1 (HCV-1), which accounts for approximately 70% of chronic infections in North America, and is relatively resistant to treatment with peginterferon and ribavirin. SVR with treatment for HCV-1 is approximately 40% (Hoofnagle 2006). That said, among HCV-1-infected individuals, there is diversity in SVR, which is correlated with a dinucleotide polymorphism at a locus upstream of the interleukin 28B (IL28B) gene. Specifically, with 48 weeks of peginterferon and ribavirin therapy, 70% of individuals with the IL28B CC polymorphism achieve SVR, compared with only 30% of individuals with other IL28B polymorphisms (Thompson 2010).

New treatments for chronic HCV-1 infection are now available. In May 2011, the Food and Drug Administration (FDA) approved telaprevir, an orally available small molecule inhibitor of the HCV-1 protease, for treatment of chronic HCV-1, to be given in combination with peginterferon and ribavirin. In HCV-1-infected patients, this three-drug regimen has been shown to confer an SVR of 75% (Jacobson 2011). However, this regimen appears to be associated with up to a nearly 1.5-fold increase in premature drug discontinuation, in comparison with a regimen of peginterferon, and ribavirin alone, largely influenced by the development of telaprevir-associated rash. Given the high responsiveness to conventional peginterferon and ribavirin among HCV-1-infected individuals with the IL28B CC polymorphism, we hypothesize SVR will not be enhanced in such individuals by the addition of telaprevir to peginterferon and ribavirin therapy. If this is correct, HCV-1-infected patients with the IL28B CC polymorphism can then be treated with comparable success with peginterferon and ribavirin alone and will therefore be spared telaprevir-associated adverse affects.

The proposed study, which is a prospective randomized open label trial (in HCV-1-infected subjects with the IL28B CC polymorphism) of treatment with telaprevir (T), peginterferon (P), and ribavirin (R) versus PR alone, will test the working hypothesis. The study design takes advantage of the concept of response-guided treatment, a strategy in which the duration of antiviral treatment is based upon the presence or absence of a rapid virological response (RVR), defined as loss of detectable serum HCV RNA within the first 4 weeks of therapy. In particular, it has been shown that HCV-1 patients who achieve RVR (and maintain undetectable HCV RNA at 12 weeks (defined as eRVR), with either PR-containing or TPR-containing regimens have comparable SVR with 24 weeks, compared with 48 weeks, of total treatment (Mangia 2008, Jacobson 2011).
Overall Status
Recruiting
Start Date
July 2011
Completion Date
June 2013 (Anticipated)
Phase
Phase 4
Study Type
Interventional
Study Design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
# Arms
2
Enrollment
240 (Anticipated)
Eligibility Criteria
Inclusion Criteria:

- Age > 18 years

- Serum Hepatitis C RNA > 10,000IU/mL

- Hepatitis C virus genotype 1

- IL28B polymorphism

Exclusion Criteria:

- Previous treatment for chronic Hepatitis C

- clinical or biological evidence of acute hepatitis, including serum ALT or AST > 300U/ml

- HIV antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease

- Contraindications to PR-based treatment:

1. uncontrolled psychiatric illness

2. active substance dependency

3. Known autoimmune disorder

4. Untreated thyroid disease

5. Uncontrolled seizure disorder

6. Pregnancy, lactation or inability to maintain contraception

7. Chronic kidney disease w/ estimated GFR< 60

8. ANC<1.5/nl, Hb<12g/dl, or platelets<75/nl

- Clinical or biochemical evidence of decompensated liver disease including:

1. History of encephalopathy, ascites, or variceal bleeding OR

2. Bilirubin > 3g/dl or INR > 1.5

- Life threatening disorder with expected median survival less than 5 years

- Inability to comply with drug regimens or testing schedule required for study

- Lack of insurance coverage for any of the study medications
Gender
Both
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers?
No
Countries
United States
Last Changed Date
2011-08-18
Interventions
NameTypeDescriptionGroup
Peginterferon alfa-2aDrug180ug subcutaneously, weeklyPR
TPR
RibavirinDrugAdministered orally twice a day as follows: (++)PR
TPR
telaprevirDrug750mg every 8 hours, orallyTPR
Drugs
Peginterferon alfa-2a
Ribavirin
telaprevir
Primary Outcome
Sustained virological response among subjects receiving a three drug versus two drug regimen of treatment
Secondary Outcome
Extended rapid virological response in patients receiving three drug versus two drug regimen
Condition
Hepatitis C
Overall Official
Tibotec Pharmaceuticals Clinical Trial
Study Director
Tibotec Pharmaceutical Limited
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Laurent COTTE, MD
Principal Investigator
Hopital Croix Rousse LYON FRANCE
Jean-Pierre ABOULKER, MD
Study Chair
INSERM SC10 VILLEJUIF FRANCE
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Michael Adler, MD, PhD
Principal Investigator
Erasmus Hospital Bruxelles
Hendrik Reesink, MD, PhD
Principal Investigator
Academic Medical Center of the University of Amsterdam
Kenneth Sherman, MD, PhD
Principal Investigator
University of Cincinnati
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Medical Monitor
Study Director
Vertex Pharmaceuticals Incorporated
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Tadashi Yoshida, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Nathalie Adda, MD
Study Director
Vertex Pharmaceuticals Incorporated
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Tibotec-Virco Virology BVBA Clinical Trial
Study Director
Tibotec BVBA
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Andrew H. Talal, MD, MPH
Principal Investigator
Weill Medical College of Cornell University
Kazuoki Kondo, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Tadashi Yoshida, MD
Study Director
Mitsubishi Tanabe Pharma Corporation
Steven Lidofsky, MD
Principal Investigator
University of Vermont & Fletcher Allen Health Care
Num. Locations
1
Num. Recruiting
1

Information obtained from ClinicalTrials.gov on September 11, 2011

8.2 Citeline TrialTrove

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Trial Title
A Randomized Trial of Telaprevir, Peginterferon, and Ribavirin Versus Peginterferon and Ribavirin for Treatment of Genotype 1 Hepatitis C Virus With Host Interleukin 28B CC Polymorphism.
Disease Type
HCV
Trial Phase
IV
Patient Segment
Chronic hepatitis C
Genotype 1
Treatment naive
Sponsorship
University of Vermont
Primary Drugs
peginterferon alfa-2a (SC)
ribavirin (oral)
telaprevir
Trial Identifier
M11-219
NCT01415141
TrialTroveID-151386
Trial Status
Open
Trial Objectives
To determine among genotype 1 hepatitis C patients with the IL28B CC polymorphism the success rate and side effects of 3-drug treatment compared with 2-drug treatment.
Primary Endpoints
Primary Outcome Measures: - Sustained virological response among subjects receiving a three drug versus two drug regimen of treatment [ Time Frame: 24 weeks after completion of treatment] [Designated as safety issue: No]. - Sustained virological response is defined as undetectable hepatitis C virus RNA in the blood at 24 weeks after the completion of antiviral treatment. This will be measured by PCR to determine the hepatitis C viral load in blood at the indicated time point.
Other Endpoints
Secondary Outcome Measures: - Extended rapid virological response in patients receiving three drug versus two drug regimen [ Time Frame: weeks 4 and 12 of treatment] [Designated as safety issue: No]. - Extended rapid virological response (eRVR) is defined as undetectable hepatitis C virus RNA in the blood at 4 and 12 weeks of treatment. This will be measured by PCR to measure viral load at the indicated time points.
Start Date
2011-07-01
Primary Endpoints Reported
2013-06-01
Patient Population
Genotype 1 hepatitis C patients with the IL28B CC polymorphism.
Inclusion Criteria
Ages Eligible for Study: 18 Years and older Inclusion Criteria: - Age > 18 years. - Serum Hepatitis C RNA > 10,000IU/mL. - Hepatitis C virus genotype 1. - IL28B polymorphism.
Exclusion Criteria
Exclusion Criteria: - Previous treatment for chronic Hepatitis C. - Clinical or biological evidence of acute hepatitis, including serum ALT or AST > 300U/ml. - HIV antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease. - Contraindications to PR-based treatment:. - Uncontrolled psychiatric illness. - Active substance dependency. - Known autoimmune disorder. - Untreated thyroid disease. - Uncontrolled seizure disorder. - Pregnancy, lactation or inability to maintain contraception. - Chronic kidney disease w/ estimated GFR< 60. - ANC < 1.5/nl, Hb < 12g/dl, or platelets < 75/nl. - Clinical or biochemical evidence of decompensated liver disease including. - History of encephalopathy, ascites, or variceal bleeding or. - Bilirubin > 3g/dl or INR > 1.5. - Life threatening disorder with expected median survival less than 5 years - Inability to comply with drug regimens or testing schedule required for study. - Lack of insurance coverage for any of the study medications.
Gender
Both
Age (Min)
18
Age (Min) Units
Years
Age (Max) Units
Years
Prior/Concurrent Therapy
N/A
Target Accrual
240
Reported Sites
1
Identified Sites
1
Actual Accrual
N/A
Trial Locations
US
Treatment Plan
N/A
Study Keywords
N/A
Study Design
Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment This is a prospective study.
Investigators / Contacts
Steven Lidofsky, MD, Responsible Party/Princial Investigator, University of Vermont & Fletcher Allen Health Care, Burlington, Vermont, United States, 05401 Phone: 802-656-8696 E-mail: steven.lidofsky@uvm.edu Contact: Erin Parker, BA Phone: 802-656-9094 E-mail: erin.parker@med.uvm.edu
Notes
Locations/Contacts Study site and Contact information (Last Updated on August 10, 2011) [last accessed on August 16, 2011]: Contact: Erin Parker, BA 802-656-9094 erin.parker@med.uvm.edu Contact: Steven Lidofsky, MD 802-656-8696 steven.lidofsky@uvm.edu United States, Vermont Fletcher Allen Health Care Recruiting Burlington, Vermont, United States, 05401 http://clinicaltrials.gov/ct2/show/NCT01415141

Study Timing: Study Start Date: July 2011 Estimated Study Completion Date: June 2014 Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure) http://clinicaltrials.gov/ct2/show/NCT01415141

Related Publications: Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: a multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010 Feb;138(2):513-21, 521.e1-6. Epub 2009 Oct 25. http://www.ncbi.nlm.nih.gov/pubmed/19861128?dopt=Abstract Hoofnagle JH, Seeff LB. Peginterferon and ribavirin for chronic hepatitis C. N Engl J Med. 2006 Dec 7;355(23):2444-51. Review. No abstract available. http://www.ncbi.nlm.nih.gov/pubmed/17151366?dopt=Abstract Mangia A, Minerva N, Bacca D, Cozzolongo R, Ricci GL, Carretta V, Vinelli F, Scotto G, Montalto G, Romano M, Cristofaro G, Mottola L, Spirito F, Andriulli A. Individualized treatment duration for hepatitis C genotype 1 patients: A randomized controlled trial. Hepatology. 2008 Jan;47(1):43-50. http://www.ncbi.nlm.nih.gov/pubmed/18069698?dopt=Abstract Seeff LB, Ghany MG. Management of untreated and nonresponder patients with chronic hepatitis C. Semin Liver Dis. 2010 Nov;30(4):348-60. Epub 2010 Oct 19. Review. http://www.ncbi.nlm.nih.gov/pubmed/20960375?dopt=Abstract Thompson AJ, Muir AJ, Sulkowski MS, Ge D, Fellay J, Shianna KV, Urban T, Afdhal NH, Jacobson IM, Esteban R, Poordad F, Lawitz EJ, McCone J, Shiffman ML, Galler GW, Lee WM, Reindollar R, King JW, Kwo PY, Ghalib RH, Freilich B, Nyberg LM, Zeuzem S, Poynard T, Vock DM, Pieper KS, Patel K, Tillmann HL, Noviello S, Koury K, Pedicone LD, Brass CA, Albrecht JK, Goldstein DB, McHutchison JG. Interleukin-28B polymorphism improves viral kinetics and is the strongest pretreatment predictor of sustained virologic response in genotype 1 hepatitis C virus. Gastroenterology. 2010 Jul;139(1):120-9.e18. Epub 2010 Apr 24. http://www.ncbi.nlm.nih.gov/pubmed/20399780?dopt=Abstract Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011 Jun 23;364(25):2405-16. http://www.ncbi.nlm.nih.gov/pubmed/21696307?dopt=Abstract http://clinicaltrials.gov/ct2/show/NCT01415141
Trial Tags
PGX
Supporting URLs
http://clinicaltrials.gov/ct2/show/NCT01415141
Last Modified
2011-08-17
Last Full Review
2011-08-16
Internal Comments
N/A
Record URL
http://jnj.citeline.com/xt_view.asp?trialid=151386&target=10
Record Number
151386
Drug Name(s)
peginterferon alfa-2a (SC)
ribavirin (oral)
telaprevir

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8.3 Adis Clinical Trials Database

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A Randomized Trial of Telaprevir, Peginterferon, and Ribavirin Versus Peginterferon and Ribavirin for Treatment of Genotype 1 Hepatitis C Virus With Host Interleukin 28B CC Polymorphism.
700204678


Study Details
Purpose
This trial will evaluate the efficacy of peginterferon alfa 2a + ribavirin alone and in combination with telaprevir, in patients with genotype 1 hepatitis C with host interleukin 28B CC polymorphism. The primary outcome is sustained virological response. This will be assessed 24 weeks after treatment completion.
Start Date: 01 Jul 2011 (actual)
End Date: 01 Jun 2014 (planned)

Details Study Design: open, parallel, randomised
Study Controls: drug combination comparison
Study Status: Recruiting
Study Phase: IV
Study Location: USA
Study Endpoint: Rapid virological response, Sustained virological response

Subjects Type: patients
Number: 240
Age: >= 18 years, adult, elderly

Patient Inclusion: - Age >18 years - Serum Hepatitis C RNA >10,000IU/mL - Hepatitis C virus genotype 1 - IL28B polymorphism.
Patient Exclusion: - Previous treatment for chronic Hepatitis C - clinical or biological evidence of acute hepatitis, including serum alanine/aspartate aminotransferase >300U/ml - HIV antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease - Contraindications to PR-based treatment: 1. uncontrolled psychiatric illness 2. active substance dependency 3. Known autoimmune disorder 4. Untreated thyroid disease 5. Uncontrolled seizure disorder 6. Pregnancy, lactation or inability to maintain contraception 7. Chronic kidney disease w/ estimated glomerular filtration rate <60 8. Absolute neutrophil count <1.5/nl, haemoglobin <12g/dl, or platelets <75/nl - Clinical or biochemical evidence of decompensated liver disease including: 1. History of encephalopathy, ascites, or variceal bleeding OR 2. Bilirubin >3g/dl or INR >1.5 - Life threatening disorder with expected median survival less than 5 years - Inability to comply with drug regimens or testing schedule required for study - Lack of insurance coverage for any of the study medications.

Ongoing Trial Comments
According to the ClinicalTrials.gov record, the estimated primary and study completion dates are June 2013 and June 2014, respectively.

Study Centre Details
NameCountryInvestigatorsContact Details
Fletcher Allen Health Care, BurlingtonUSAParker EPhone: 802-656-9094E-mail: erin.parker@med.uvm.edu
University of Vermont and Fletcher Allen Health Care, BurlingtonUSALidofsky SPhone: 802-656-8696E-mail: steven.lidofsky@uvm.edu
University of Vermont   

Study Status History
DateEventCommentUpdate Date
26/08/2011Other trial eventProfile reviewed.26/08/2011
18/08/2011Other trial eventLast checked against ClinicalTrials.gov record.26/08/2011
15/08/2011New trial recordNew trial record15/08/2011

Disease Treated
IndicationPatient Segment
Hepatitis-Cgenotype 1
Hepatitis-Ctreatment-naive

Treatments
NameDoseRouteFreqDur.
Peginterferon alfa 2a180 µg/weekSC1/week<=48 weeks
Ribavirin2000-2400 mg/dayPObid<=48 weeks
Telaprevir750 mg/dosePOq8h12 weeks


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