Conditions: Chronic Hepatitis C
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 167
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to assess the change in Hepatitis C Virus RNA during dosing with daclatasvir and during the follow-up period in subjects with chronic hepatitis C infection

Detailed description:

Arms:
arm 1: Daclatasvir (1 mg), once daily

or

Matching Placebo, once daily arm 2: Daclatasvir (10 mg), once daily

or

Matching Placebo, once daily arm 3: Daclatasvir (1-100 mg), once or twice daily

or

Matching Placebo, once or twice daily arm 4: Daclatasvir (1-100 mg), once or twice daily

or

Matching Placebo, once or twice daily arm 5: Group 5: Active Comparator

Daclatasvir (1-100 mg), once or twice daily

or

Matching Placebo, once or twice daily arm 6: Group 6: Active Comparator

Daclatasvir (1-100 mg), once or twice daily

or

Matching Placebo, once or twice daily

Interventions: intervention 1: Daclatasvir intervention 2: Placebo
Intervention descriptions: intervention 1: Capsule, Oral, Approximately 182 days from initial dosing intervention 2: Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel

Protocol document: