Conditions: Hepatitis C
Keywords: Chronic hepatitis C Cyclophilin inhibitor
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 8
Healthy volunteers: no

Brief summary:
This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC), each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African American participants who have never received treatment for their chronic hepatitis C (HCV) genotype 1 infection.

Detailed description:

Arms:
arm 1: At the time of partial clinical hold, participants randomized to original treatment arms A and B (Alisporivir triple therapy arms with Peginterferon alfa-2a and Ribavirin) discontinued alisporivir treatment immediately while continuing their treatments with the other two therapies. These participants were combined into the same arm because they received the same dose of alisporivir 400 mg twice per day (BID) for the same duration. Amendment 1 offered them the opportunity to continue in the study receiving boceprevir triple therapy. arm 2: Participants randomized to boceprevir triple therapy with Peginterferon alfa-2a and Ribavirin (the original treatment arm C).

Interventions: intervention 1: Alisporivir intervention 2: Boceprevir intervention 3: Peginterferon alfa-2a intervention 4: Ribavirin
Intervention descriptions: intervention 1: ALV 200 mg soft gel capsules administered orally intervention 2: BOC 800 mg (4 x 200 mg soft gel capsules) administered orally intervention 3: PEG 180 μg administered via subcutaneous (s.c.) injection once weekly intervention 4: RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose

Protocol document: