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S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis

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.
 
ClinicalTrials.gov Identifier: NCT00108589
Recruitment Status : Completed
First Posted : April 18, 2005
Last Update Posted : January 21, 2009
Sponsor:
Information provided by:
VA Office of Research and Development

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis Drug: S-adenosylmethionine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis
Study Start Date : January 2004
Study Completion Date : December 2006

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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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): NCT00108589


Locations
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United States, Kentucky
VA Medical Center
Louisville, Kentucky, United States, 40206
Sponsors and Collaborators
US Department of Veterans Affairs
More Information
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ClinicalTrials.gov Identifier: NCT00108589    
Other Study ID Numbers: CLIN-014-03S
First Posted: April 18, 2005    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: May 2007
Keywords provided by VA Office of Research and Development:
s-adenosylmethionine
fatty liver
obesity
Non-alcoholic steatohepatitis
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases