Status:
COMPLETED
Peak Study - A Study of Pegasys (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC).
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 i...
Eligibility Criteria
Inclusion
- 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
- previous systemic therapy with anti-viral, anti-neoplastic, or immunomodulatory agents
- medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure)
- decompensated liver disease
- women who are pregnant or breastfeeding
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
385 Patients enrolled
Trial Details
Trial ID
NCT00087607
Start Date
January 1 2004
End Date
April 1 2006
Last Update
July 1 2016
Active Locations (41)
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1
Birmingham, Alabama, United States, 35295-0005
2
Little Rock, Arkansas, United States, 72205
3
Sacramento, California, United States, 95817
4
San Diego, California, United States, 92103