Conditions: Hepatitis C Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 55
Healthy volunteers: no

Brief summary:
The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious

Detailed description:

Arms:
arm 1: Treatment Naive arm 2: Treatment Naive arm 3: Treatment Naive arm 4: Non-Responder arm 5: Non-Responder

Interventions: intervention 1: Daclatasvir intervention 2: Daclatasvir intervention 3: Placebo intervention 4: Peginterferon alfa-2a intervention 5: Ribavirin
Intervention descriptions: intervention 1: Tablets, Oral, 10 mg, daily, 24-48 weeks intervention 2: Tablets, Oral, 60 mg, daily, 24-48 weeks intervention 3: Tablets, Oral, 0 mg, daily, 48 weeks intervention 4: Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks intervention 5: Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks

Protocol document: