Conditions: Hepatitis Hepatitis C
Keywords: Hepatitis C Polymerase Inhibitor PF-00868554 Filibuvir
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 288
Healthy volunteers: no

Brief summary:
The primary objective for this study is to determine if the addition of filibuvir to a standard regimen of peginterferon/ribavirin (pegIFN/RBV) significantly increases the proportion of subjects who achieve a sustained viral response (SVR) compared to peginterferon/ribavirin (pegIFN/RBV) therapy alone.

Detailed description:

Arms:
arm 1: Filibuvir 300 mg BID + pegIFN/RBV x 24 weeks (subjects with undetectable HCV RNA at week 4)

\- or - Filibuvir 300 mg BID + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks (subjects with detectable HCV RNA at week 4) arm 2: Filibuvir 600 mg BID + pegIFN/RBV x 24 weeks (subjects with undetectable HCV RNA at week 4)

\- or - Filibuvir 600 mg BID + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks (subjects with detectable HCV RNA at week 4) arm 3: Placebo + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks

Interventions: intervention 1: Filibuvir intervention 2: Filibuvir intervention 3: Placebo
Intervention descriptions: intervention 1: 300 mg BID intervention 2: 600 mg BID intervention 3: BID

Protocol document: