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S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis

This study has been completed.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00108589
  Purpose

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
Hepatitis
Drug: S-adenosylmethionine
Phase III

MedlinePlus related topics:   Hepatitis   

ChemIDplus related topics:   S-Adenosylmethionine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:   S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis

Further study details as provided by Department of Veterans Affairs:

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

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108589

Locations
United States, Kentucky
VA Medical Center    
      Louisville, Kentucky, United States, 40206

Sponsors and Collaborators
  More Information

Study ID Numbers:   CLIN-014-03S
First Received:   April 15, 2005
Last Updated:   May 15, 2007
ClinicalTrials.gov Identifier:   NCT00108589
Health Authority:   United States: Federal Government

Keywords provided by Department of Veterans Affairs:
s-adenosylmethionine  
fatty liver  
obesity  
Non-alcoholic steatohepatitis  

Study placed in the following topic categories:
Hepatitis
Obesity
Liver Diseases
Digestive System Diseases
Fatty Liver

ClinicalTrials.gov processed this record on September 04, 2008




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