S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis

This study has been completed.

First Received on April 15, 2005. Last Updated on January 20, 2009 History of Changes

Sponsor:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00108589

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 III

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:

MedlinePlus related topics: Hepatitis Hepatitis A

Drug Information available for: S-Adenosylmethionine

U.S. FDA Resources

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

Department of Veterans Affairs

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 February 12, 2012