S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108589
First received: April 15, 2005
Last updated: January 20, 2009
Last verified: May 2007

April 15, 2005
January 20, 2009
January 2004
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Complete list of historical versions of study NCT00108589 on ClinicalTrials.gov Archive Site
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S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis
S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis

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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hepatitis
Drug: S-adenosylmethionine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2006
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Inclusion Criteria:

  • Men with biopsy proven non-alcoholic steatohepatitis from the liver disease clinic or referred from other physicians from the VAMC-Louisville.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00108589
CLIN-014-03S
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Department of Veterans Affairs
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Department of Veterans Affairs
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP