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Antiviral & Antifibrotic Liver Therapy in HCV + Drinkers and Non-Drinkers

NCT00211848 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2017-01-27

No results posted yet for this study

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.

Conditions

  • Hepatitis C

Interventions

DRUG

Polyenylphosphatidylcholine (PPC)

DRUG

Pegylated Interferon

DRUG

Ribavirin

Sponsors & Collaborators

Principal Investigators

  • Charles S Lieber, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-06-30
Primary Completion
2005-12-31
Completion
2005-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00211848 on ClinicalTrials.gov