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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Peginterferon alfa-2a

Criteria

Inclusion Criteria:

• Treatment naive (no prior treatment with IFN-a +/- RBV regimens.

• Subjects who have discontinued IFN-a containing regimens after <2 weeks of therapy due to tolerability issues are considered treatment naive.

• HCV RNA > 100,000 IU/mL at screening.

• Genotype 1.

• A diagnosis of chronic HCV infection for at least 6 months.

Exclusion Criteria:

• Evidence of acute or chronic infection with HIV or HBV.

• Exposure within the previous three months to an investigational anti-HCV agent.

• Evidence of severe or decompensated liver disease.

• Subjects with liver disease unrelated to HCV infection.