A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/3/2016 |
| Start Date: | September 2006 |
| End Date: | August 2008 |
A Randomized, Double-blind Study to Evaluate the Safety and Tolerability of the HCV Polymerase Inhibitor Pro-drug in Combination With Pegasys, With or Without Copegus, Versus Pegasys Plus Copegus, in Treatment-naïve Patients With Chronic Hepatitis C, Genotype 1
This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor
pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of
PEGASYS + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be
randomized to receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug +
PEGASYS, 1500mg of HCV polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS +
COPEGUS for 4 weeks. All patients who receive at least one dose of study medication will
receive open label PEGASYS + Copegus for an additional 44 weeks after the 4 week
experimental period. The anticipated time on study treatment is 3-12 months, and the target
sample size is <100 individuals.
pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of
PEGASYS + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be
randomized to receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug +
PEGASYS, 1500mg of HCV polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS +
COPEGUS for 4 weeks. All patients who receive at least one dose of study medication will
receive open label PEGASYS + Copegus for an additional 44 weeks after the 4 week
experimental period. The anticipated time on study treatment is 3-12 months, and the target
sample size is <100 individuals.
Inclusion Criteria:
- adult patients, 18-65 years of age;
- CHC without liver cirrhosis or incomplete/transition to liver cirrhosis, genotype 1;
- chronic liver disease consistent with CHC.
Exclusion Criteria:
- infection with any HCV genotype other than genotype 1;
- previous treatment for CHC;
- medical condition associated with chronic liver disease other than CHC;
- HIV, Hepatitis A, Hepatitis B infection.
We found this trial at
17
sites
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