S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis

This study has been completed.
Information provided by:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
First received: April 15, 2005
Last updated: January 20, 2009
Last verified: May 2007

The purpose of this study is to examine the effect of S-adenosylmethionine therapy in those patients with non-alcoholic liver disease in the form of steatohepatitis (NASH). This will be accomplished by development of a database of these patients, all of whom will have biopsy documented NASH. A placebo controlled trial will then examine the effect of S-adenosylmethionine over time on clinical outcome in these patients. It is expected that this agent will slow or halt the progression of this disease.

Condition Intervention Phase
Drug: S-adenosylmethionine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Study Start Date: January 2004
Estimated Study Completion Date: December 2006

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men with biopsy proven non-alcoholic steatohepatitis from the liver disease clinic or referred from other physicians from the VAMC-Louisville.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00108589

United States, Kentucky
VA Medical Center
Louisville, Kentucky, United States, 40206
Sponsors and Collaborators
VA Office of Research and Development
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00108589     History of Changes
Other Study ID Numbers: CLIN-014-03S
Study First Received: April 15, 2005
Last Updated: January 20, 2009
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
fatty liver
Non-alcoholic steatohepatitis

ClinicalTrials.gov processed this record on October 07, 2015