A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection

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).

Timeline

Start

2008-08

Primary completion

2010-03

Completion

2010-03

Outcome

Met primary endpoint

registry PF-00868554 200 mg + pegIFN Alfa-2a/RBV vs Placebo + pegIFN Alfa-2a/RBV; p = 0.0131; Adjusted Mean Difference -2.36357 NCT00720434 ↗

registry PF-00868554 300 mg + pegIFN Alfa-2a/RBV vs Placebo + pegIFN Alfa-2a/RBV; p = 0.0142; Adjusted Mean Difference -2.49190 NCT00720434 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Filibuvir	Small molecule	200 mg	—
Subject	Filibuvir	Small molecule	300 mg	—
Subject	Filibuvir	Small molecule	500 mg	—

Indications