Conditions: Hepatitis C Infection
Keywords: Antivirals
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 74
Healthy volunteers: no

Brief summary:
The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.

Detailed description:

Arms:
arm 1: Active Comparator arm 2: Active Comparator arm 3: Active Comparator arm 4: None

Interventions: intervention 1: Daclatasvir intervention 2: Daclatasvir intervention 3: Daclatasvir intervention 4: Placebo intervention 5: Peginterferon alpha-2a intervention 6: ribavirin
Intervention descriptions: intervention 1: Tablets, oral, 3 mg, Daily, 48 weeks intervention 2: Tablets, oral, 10 mg, Daily, 48 weeks intervention 3: Tablets, oral, 60 mg, Daily, 48 weeks intervention 4: Tablet, oral, 0 mg, Daily 48 weeks intervention 5: Syringe, subcutaneous, 180 µg, Weekly, 48 weeks intervention 6: Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks

Protocol document: