Conditions: Hepatitis C Virus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 196
Healthy volunteers: no

Brief summary:
To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.

Detailed description:

Arms:
arm 1: Placebo + Pegylated interferon alfa-2a + Ribavirin arm 2: Daclatasvir + Pegylated interferon alfa-2a + Ribavirin arm 3: Daclatasvir + Pegylated interferon alfa-2a + Ribavirin

Interventions: intervention 1: Placebo intervention 2: Daclatasvir intervention 3: Pegylated interferon alfa-2a intervention 4: Ribavirin
Intervention descriptions: intervention 1: Tablets, oral, 0 mg, once daily, for 24 weeks intervention 2: Tablets, oral, 60 mg, once daily, for 12, 16, or 24 weeks intervention 3: Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks intervention 4: Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks

Protocol document: