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
  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 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 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

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Fatty Liver
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on April 16, 2014