S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis - Tabular View

Tracking Information
First Received Date ^ICMJE	April 15, 2005
Last Updated Date	January 20, 2009
Start Date ^ICMJE	January 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00108589 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis
Official Title ^ICMJE	S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis
Brief 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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Condition ^ICMJE	Hepatitis
Intervention ^ICMJE	Drug: S-adenosylmethionine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date	December 2006
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Men with biopsy proven non-alcoholic steatohepatitis from the liver disease clinic or referred from other physicians from the VAMC-Louisville.
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00108589
Responsible Party
Study ID Numbers ^ICMJE	CLIN-014-03S
Study Sponsor ^ICMJE	Department of Veterans Affairs
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Department of Veterans Affairs
Verification Date	May 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP