PEAK Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC).
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2003 |
| End Date: | May 2006 |
A Randomized, Open-label Study to Compare the Effect of PEGASYS Plus Ribavirin and PEG-Intron Plus Ribavirin on Viral Load Reduction in Interferon-naïve Patients With Chronic Hepatitis C Viral Infection
This study will examine the viral kinetics and pharmacokinetics of PEGASYS plus ribavirin
and PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on
study treatment is 3-12 months, and the target sample size is 100-500 individuals.
and PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on
study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Inclusion Criteria:
- adult patients at least 18 years of age
- CHC infection, genotype 1
- use of 2 forms of contraception during study in both men and women
Exclusion Criteria:
- previous systemic therapy with anti-viral, anti-neoplastic, or immunomodulatory
agents
- medical condition associated with chronic liver disease (eg, hemochromatosis,
autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin
exposure)
- decompensated liver disease
- women who are pregnant or breastfeeding
We found this trial at
42
sites
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