Conditions: Hepatitis C Virus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 558
Healthy volunteers: no

Brief summary:
To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Daclatasvir intervention 2: Daclatasvir intervention 3: Placebo intervention 4: peg-interferon alfa-2a intervention 5: ribavirin
Intervention descriptions: intervention 1: Tablets, oral, 20 mg, once daily, 12-24 weeks, depending on response intervention 2: Tablets, oral, 60 mg, once daily, 12-24 weeks, depending on response intervention 3: Tablets, oral, 0 mg, once daily, 24 weeks intervention 4: Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response intervention 5: Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response

Protocol document: