Conditions: Hepatitis C
Keywords: Genotype 1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 540
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: 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 arm 2: 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 arm 3: 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 arm 4: 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.

Interventions: intervention 1: telaprevir intervention 2: ribavirin intervention 3: peginterferon alfa-2a
Intervention descriptions: intervention 1: 750 mg every 8 hours (q8h) for 12 weeks intervention 2: 1000 - 1200 mg/day based on body weight for either 24 or 48 weeks intervention 3: 180 mcg/week for either 24 or 48 weeks

Protocol document: