Status:
COMPLETED
A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection
Lead Sponsor:
Pfizer
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00720434
Start Date
August 1 2008
End Date
March 1 2010
Last Update
August 26 2013
Active Locations (10)
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1
Pfizer Investigational Site
La Jolla, California, United States, 92037
2
Pfizer Investigational Site
San Francisco, California, United States, 94115
3
Pfizer Investigational Site
Orlando, Florida, United States, 32803
4
Pfizer Investigational Site
Springfield, Massachusetts, United States, 01107