S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis

Hepatitis Clinical Trial

Official title:

S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00108589
• Other study ID #: CLIN-014-03S
• Status: Completed
• Phase: Phase 3
• First received: April 15, 2005
• Last updated: January 20, 2009
• Start date: January 2004
• Est. completion date: December 2006

Study information

• Verified date: May 2007
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men with biopsy proven non-alcoholic steatohepatitis from the liver disease clinic or referred from other physicians from the VAMC-Louisville.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Hepatitis

Intervention

Drug:
• S-adenosylmethionine

Locations

Country	Name	City	State
United States	VA Medical Center	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States,