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.

Completed

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Key information

Conditions

Hepatitis Body Weight Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

VA Medical Center

Louisville, Kentucky, 40206, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

S-adenosylmethionine

Drug

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start: 2004
Study completion: 2006
First posted: Apr 18, 2005
Registry last updated: Jan 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed