Status:
COMPLETED
Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
569 Patients enrolled
Trial Details
Trial ID
NCT00107653
Start Date
October 1 2004
End Date
September 1 2007
Last Update
June 21 2016
Active Locations (60)
Enter a location and click search to find clinical trials sorted by distance.
1
Scottsdale, Arizona, United States, 85259
2
Tucson, Arizona, United States, 85712
3
Anaheim, California, United States, 92801
4
Fountain Valley, California, United States, 92708