A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response

Study Overview
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Brief Summary
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This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.

Official Title
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A Randomized Study of Stopping Treatment at 24 Weeks or Continuing Treatment to 48 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response While Receiving Telaprevir, Peginterferon Alfa2a (Pegasys®) and Ribavirin (Copegus®)

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: telaprevir
* Drug: ribavirin
* Biological: peginterferon alfa-2a


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C Male and female subjects, 18 to 70 years of age, inclusive Genotype 1, chronic hepatitis C with detectable HCV RNA. Screening laboratory values, tests, and physical exam within acceptable ranges Able and willing to follow contraception requirements Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions. Exclusion Criteria: Subject has any contraindications to Pegasys® or Copegus® therapy Evidence of hepatic decompensation in cirrhotic subjects History of organ transplant History of, or any current medical condition which could impact the safety of the subject in participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T12PR24 (eRVR+)<br>Randomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 12 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group | Drug: telaprevir<br>* 750 mg every 8 hours (q8h) for 12 weeks<br>* Other names: VX-950;Drug: ribavirin<br>* 1000 - 1200 mg/day based on body weight for either 24 or 48 weeks<br>* Other names: Copegus;Biological: peginterferon alfa-2a<br>* 180 mcg/week for either 24 or 48 weeks<br>* Other names: Pegasys;|
| Experimental: T12PR48 (eRVR+)<br>Randomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group | Drug: telaprevir<br>* 750 mg every 8 hours (q8h) for 12 weeks<br>* Other names: VX-950;Drug: ribavirin<br>* 1000 - 1200 mg/day based on body weight for either 24 or 48 weeks<br>* Other names: Copegus;Biological: peginterferon alfa-2a<br>* 180 mcg/week for either 24 or 48 weeks<br>* Other names: Pegasys;|
| Experimental: T12PR48 (eRVR-)<br>Assigned Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects did not achieve an extended rapid viral response and were assigned to this group | Drug: telaprevir<br>* 750 mg every 8 hours (q8h) for 12 weeks<br>* Other names: VX-950;Drug: ribavirin<br>* 1000 - 1200 mg/day based on body weight for either 24 or 48 weeks<br>* Other names: Copegus;Biological: peginterferon alfa-2a<br>* 180 mcg/week for either 24 or 48 weeks<br>* Other names: Pegasys;|
| Experimental: Other<br>Other Group: Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen. | Drug: telaprevir<br>* 750 mg every 8 hours (q8h) for 12 weeks<br>* Other names: VX-950;Drug: ribavirin<br>* 1000 - 1200 mg/day based on body weight for either 24 or 48 weeks<br>* Other names: Copegus;Biological: peginterferon alfa-2a<br>* 180 mcg/week for either 24 or 48 weeks<br>* Other names: Pegasys;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24) | SVR24planned was used to measure the primary outcome. SVR24 planned is defined as undetectable HCV RNA levels at the end of treatment (EOT) visit and at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA levels in between those visits. All plasma HCV RNA levels were assessed using the Roche TaqMan HCV RNA assay (Version 2.0, lower limit of quantification [LLOQ] of 25 IU/mL). | 24 weeks after the last planned dose of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Who Have Undetectable HCV RNA at Week 72 | SVR at Week 72 is defined as achieved SVR24planned and undetectable HCV RNA at Week 72 without any confirmed detectable HCV RNA levels in between those visits. | 72 weeks after the last planned dose of study treatment | 
| Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12 | Extended rapid viral response is defined undetectable HCV RNA levels at Week 4 and Week 12 (on treatment). | Week 4 and Week 12 | 
| Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment | SVR12 is defined as undetectable HCV RNA levels 12 weeks after the last planned dose of study treatment. | 12 weeks after last dose of study treatment | 
| Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively) |  | Week 24 or Week 48 | 
| Proportion of Randomized Subjects Who Relapse | Proportion of randomized subjects who relapsed was defined as the number of subjects who completed treatment, had undetectable HCV RNA at end of treatment (EOT; Week 24 or Week 48 respectively), and became HCV RNA detectable during antiviral follow-up (24 weeks after EOT). | From EOT to Week 48 or Week 72 | 
| Proportion of Enrolled Subjects Who Relapse | Proportion of enrolled subjects who relapsed was defined as the number of subjects who had undetectable HCV RNA at the EOT, and became HCV RNA detectable during antiviral follow-up. | From EOT to Week 48 or Week 72 | 
| Safety and Tolerability as Assessed by Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Day 1 up to Week 72 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genotype 1