Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ patients.

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

Details

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

Criteria

Inclusion Criteria:

• adult patients 18-65 years of age

• chronic hepatitis C , genotype 1

• serologic evidence of CHC infection by an antibody test

• chronic liver disease, consistent with CHC infection on a liver biopsy obtained within the past 18 months

• compensated liver disease

• use of 2 forms of contraception during the study in both men and women

Exclusion Criteria:

• previous interferon or ribavirin therapy

• systemic antiviral therapy less than 24 weeks before first dose of study drug or expected need for this treatment any time during the study

• medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)

• decompensated liver disease

• women who are pregnant or breastfeeding