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
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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 is 3-12 months, and the target sample size is 100-500 individuals.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Interferon-alpha; Interferons; Peginterferon alfa-2a; Peginterferon alfa-2b; Ribavirin

Criteria

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 (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure)

• decompensated liver disease

• women who are pregnant or breastfeeding