Antiviral & Antifibrotic Liver Therapy in HCV + Drinkers and Non-Drinkers
Status:
Completed
Trial end date:
2005-12-01
Target enrollment:
Participant gender:
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 either abstain from alcohol or continue to drink. All subjects are given
state-of-the-art antiviral treatment (pegylated interferon + ribavirin), supplemented with
either placebo or polyenylphosphatidylcholine (PPC), a purified soybean extract consisting of
95-96% polyunsaturated phosphatidylcholines (PC) and which has both antifibrotic and
antioxidant properties. Secondary aims are to verify whether moderate alcohol consumption
interferes with the antiviral effect of pegylated interferon + ribavirin on HCV and to
validate the reliability of various circulating markers as substitute for liver biopsies to
indicate the stage of liver pathology and its propensity for progression.
Phase:
Phase 2
Details
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborators:
Hoffmann-La Roche National Institute on Alcohol Abuse and Alcoholism (NIAAA)