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Sponsors and Collaborators: |
Mount Sinai School of Medicine National Institute on Alcohol Abuse and Alcoholism (NIAAA) Hoffmann-La Roche |
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Information provided by: | Mount Sinai School of Medicine |
ClinicalTrials.gov Identifier: | NCT00211848 |
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.
Condition | Intervention | Phase |
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Hepatitis C |
Drug: Polyenylphosphatidylcholine (PPC) Drug: Pegylated Interferon Drug: Ribavirin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Antiviral & Antifibrotic Liver Therapy in HCV + Drinkers and Non-Drinkers |
Estimated Enrollment: | 207 |
Study Start Date: | June 2000 |
Estimated Study Completion Date: | December 2005 |
Ages Eligible for Study: | 21 Years to 67 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
-
United States, New York | |
Bronx VA | |
Bronx, New York, United States, 10468-3922 |
Principal Investigator: | Charles S Lieber, MD | Mount Sinai School of Medicine |
Study ID Numbers: | AA12867, 99-1097 |
Study First Received: | September 13, 2005 |
Last Updated: | April 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00211848 |
Health Authority: | United States: Food and Drug Administration |
Chemical Compounds-drugs Human Subjects- adults Gastrointestinal System-liver Pathology |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Interferons Ribavirin Hepatitis, Viral, Human Hepatitis C |
RNA Virus Infections Flaviviridae Infections |