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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Mount Sinai School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Hoffmann-La Roche
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00211848
First received: September 13, 2005
Last updated: April 27, 2007
Last verified: April 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Antiviral & Antifibrotic Liver Therapy in HCV + Drinkers and Non-Drinkers

Resource links provided by NLM:

U.S. FDA Resources

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

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
Estimated Study Completion Date: December 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 67 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211848

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

No publications provided

ClinicalTrials.gov Identifier: NCT00211848     History of Changes
Other Study ID Numbers: AA12867, 99-1097
Study First Received: September 13, 2005
Last Updated: April 27, 2007
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 23, 2013