A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection
Completed · Phase 2 · Has a placebo group
Conditions studied: Hepatitis C
In brief
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).
Key facts
- Study ID
- NCT00720434
- Run by
- Pfizer
- People needed
- 35
- Starts
- 2008-08-01
- Expected to finish
- 2010-03-01
- Last updated by the study team
- 2013-08-26
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Pfizer Investigational Site — La Jolla, California, United States
- Pfizer Investigational Site — San Francisco, California, United States
- Pfizer Investigational Site — Orlando, Florida, United States
- Pfizer Investigational Site — Springfield, Massachusetts, United States
- Pfizer Investigational Site — New York, New York, United States
- Pfizer Investigational Site — New York, New York, United States
- Pfizer Investigational Site — Tulsa, Oklahoma, United States
- Pfizer Investigational Site — Nashville, Tennessee, United States
- Pfizer Investigational Site — San Antonio, Texas, United States
- Pfizer Investigational Site — Santurce, Puerto Rico
Full record on ClinicalTrials.gov
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