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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00211848
First Posted: September 21, 2005
Last Update Posted: January 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Hoffmann-La Roche
Information provided by:
Icahn School of Medicine at Mount Sinai
  Purpose
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
Hepatitis C Drug: Polyenylphosphatidylcholine (PPC) Drug: Pegylated Interferon Drug: Ribavirin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Antiviral & Antifibrotic Liver Therapy in HCV + Drinkers and Non-Drinkers

Resource links provided by NLM:


Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • To evaluate the effect of a combined antiviral, antifibrotic and antioxidant treatment on the progression of liver disease in patients with hepatitis C who abstain from alcohol or consume it.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 207
Study Start Date: June 2000
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 67 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211848


Locations
United States, New York
Bronx VA
Bronx, New York, United States, 10468-3922
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Hoffmann-La Roche
Investigators
Principal Investigator: Charles S Lieber, MD Icahn School of Medicine at Mount Sinai
  More Information

ClinicalTrials.gov Identifier: NCT00211848     History of Changes
Other Study ID Numbers: AA12867
99-1097
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: January 27, 2017
Last Verified: April 2007

Keywords provided by Icahn School of Medicine at Mount Sinai:
Chemical Compounds-drugs
Human Subjects- adults
Gastrointestinal System-liver
Pathology

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Interferons
Ribavirin
Antiviral Agents
Antineoplastic Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action