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 |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | August 2004 |
| End Date: | February 2008 |
An Open-label Study of PEGASYS Plus Ribavirin on Sustained Virological Response in Treatment-naïve Latino White Patients Compared With Non-Latino Caucasian Patients With Chronic Hepatitis C, Genotype 1
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.
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.
Inclusion Criteria:
- adult patients 18-65 years of age
- CHC, 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
We found this trial at
50
sites
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