Conditions: Hepatitis C, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 294
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) versus treatment with peg-IFN and RBV alone in Japanese treatment-naïve participants with chronic hepatitis C (CHC) genotype (GT)1. The primary efficacy hypothesis is that the percentage of participants achieving sustained virologic response 24 weeks after completion of all study therapy (SVR24) in at least one of the vaniprevir arms is superior to the percentage of participants achieving SVR24 in the control arm.

Detailed description:

Arms:
arm 1: Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV. arm 2: Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV. arm 3: Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.

Interventions: intervention 1: vaniprevir intervention 2: Placebo to vaniprevir intervention 3: Peg-IFN intervention 4: ribavirin
Intervention descriptions: intervention 1: Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks intervention 2: Placebo to vaniprevir, capsules, orally, twice daily for 12 weeks or 24 weeks intervention 3: Peg-IFN 1.5 μg/kg once per week, subcutaneously (SC) for 24 or 48 weeks intervention 4: Capsules containing 200 mg RBV orally, 3 to 5 capsules, dosage based on the participant's weight (600 mg/day to 1000 mg/day), for 24 or 48 weeks

Protocol document: