Conditions: Chronic Hepatitis C
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 350
Healthy volunteers: no

Brief summary:
The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment

Detailed description:

Arms:
arm 1: Genotype 1a or 1b arm 2: Genotype 2 or 3 arm 3: Genotype 1a or 1b arm 4: Genotype 2 or 3 arm 5: Genotype 1a or 1b arm 6: Genotype 2 or 3 arm 7: Hepatitis C virus genotype 1, treatment-naive patients

Genotype 1a or 1b arm 8: Hepatitis C virus genotype 1, treatment-naive patients

Genotype 1a or 1b arm 9: Patients who experienced telaprevir/boceprevir treatment failure

Genotype 1a or 1b arm 10: Patients who experienced telaprevir/boceprevir treatment failure

Genotype 1a or 1b

Interventions: intervention 1: PSI-7977 intervention 2: Daclatasvir intervention 3: Ribavirin
Intervention descriptions: intervention 1: Tablets, oral, 400 mg, once daily intervention 2: Tablets, oral, 60 mg, once daily intervention 3: Tablets, oral, 200 mg

Protocol document: