Status:
COMPLETED
Antiviral & Antifibrotic Liver Therapy in HCV + Drinkers and Non-Drinkers
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Hoffmann-La Roche
Conditions:
Hepatitis C
Eligibility:
All Genders
21-67 years
Phase:
PHASE2
Brief Summary
The primary aim of this investigation is to evaluate the effect of a combined antiviral, antifibrotic and antioxidant treatment on the progression of liver disease in patients with hepatitis C who eit...
Detailed Description
Current therapy for HCV disease focuses on anti-viral treatment. The combination of pegylated interferon and ribavirin is approved by the FDA for treating HCV disease. Subjects in this study will be g...
Eligibility Criteria
Inclusion
- Adult patients (up to 67 years old) are eligible for the study if they are positive for HCV RNA on testing with the polymerase chain reaction (quantitative test), or qualitative test positive if quantitative negative, have undergone a liver biopsy within one year before entry, available for analysis (vide infra) and whose results are consistent with a diagnosis of chronic hepatitis with at least moderate inflammation, a fibrosis score of at least 2/6 according to Ishak et al (1995), and excluding complete cirrhosis. In terms of drinking, the men comprise "abstainers" (less than 12 drinks in the past year), those who drink lightly (1-13 drinks per month) or moderately (4-14 drinks per week) (Dufour, 1999). For women below the age of 50 years, these levels are reduced in half. A drink is defined as: 12 ounces of regular beer, 5 ounces of wine or 1.5 ounces of distilled spirits (80 proof) (Nutrition and Your Health, 1990).
Exclusion
- \-
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2005
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT00211848
Start Date
June 1 2000
End Date
December 1 2005
Last Update
January 27 2017
Active Locations (1)
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1
Bronx VA
The Bronx, New York, United States, 10468-3922