Expired Study
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Los Angeles, California 90095


Purpose:

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.


Criteria:

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


NCT ID:

NCT00107653


Primary Contact:

Study Director
Clinical Trials
Hoffmann-La Roche


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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