S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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S-adenosylmethionine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Locations

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VA Medical Center

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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CLIN-014-03S

Identifier Type: -

Identifier Source: org_study_id

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