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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 18, 2014