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A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection - NCT00720434-92037(Clinical Trial 232768)



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City:  La Jolla
State:  
CA
Zip Code: 92037
Conditions: Hepatitis C
Purpose: 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).
Study summary:
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.
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Data Source: ClinicalTrials.gov
Date Processed: March 16, 2010
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