Conditions: Hepatitis C
Keywords: hepatitis C virus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 152
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).

Detailed description:

Arms:
arm 1: * BMS-790052 60 mg Tablets, Oral, once daily for 24 weeks
* PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 24 or 48 weeks depending on response
* Ribavirin 400 mg (2 tablets for participants \< 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 24 or 48 weeks depending on response arm 2: * Placebo matching BMS-790052 0 mg Tablets, Oral, once daily for 48 weeks
* PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 48 weeks
* Ribavirin 400 mg (2 tablets for participants \< 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 48 weeks

Interventions: intervention 1: BMS-790052 (NS5A Replication Complex Inhibitor) intervention 2: Placebo matching BMS-790052 intervention 3: Pegylated-interferon alfa 2a intervention 4: Ribavirin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: