Back to resultsS-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis
Primary Purpose
Hepatitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
S-adenosylmethionine
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis focused on measuring s-adenosylmethionine, fatty liver, obesity, Non-alcoholic steatohepatitis
Eligibility Criteria
Inclusion Criteria: Men with biopsy proven non-alcoholic steatohepatitis from the liver disease clinic or referred from other physicians from the VAMC-Louisville.
Sites / Locations
- VA Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00108589
First Posted
April 15, 2005
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00108589
Brief Title
S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis
Official Title
S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis
Keywords
s-adenosylmethionine, fatty liver, obesity, Non-alcoholic steatohepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
S-adenosylmethionine
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men with biopsy proven non-alcoholic steatohepatitis from the liver disease clinic or referred from other physicians from the VAMC-Louisville.
Facility Information:
Facility Name
VA Medical Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
12. IPD Sharing Statement
Learn more about this trial
S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis
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