Conditions: Hepatitis C
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 35
Healthy volunteers: no

Brief summary:
The purpose of this study is to further assess the potency of PF-00868554, an HCV polymerase inhibitor, in subjects chronically infected with HCV by evaluating the antiviral activity of PF-00868554 in combination with current standard of care therapy, pegylated interferon-alpha2a (PEGASYS) and ribavirin (COPEGUS).

Detailed description:

Arms:
arm 1: 500 mg BID arm 2: 300 mg BID arm 3: 200 mg BID arm 4: Placebo

Interventions: intervention 1: PF-00868554 intervention 2: PF-00868554 intervention 3: PF-00868554 intervention 4: Placebo
Intervention descriptions: intervention 1: 500 mg BID administered as 5x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks. intervention 2: 300 mg BID administered as 3x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks intervention 3: 200 mg BID administered as 2x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks intervention 4: Placebo administered for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks

Protocol document: