NCT00108589

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

January 21, 2009

Status Verified

May 1, 2007

First QC Date

April 15, 2005

Last Update Submit

January 20, 2009

Conditions

Hepatitis

Keywords

s-adenosylmethioninefatty liverobesityNon-alcoholic steatohepatitis

Interventions

S-adenosylmethionineDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center

Louisville, Kentucky, 40206, United States

Location

MeSH Terms

Conditions

HepatitisFatty LiverObesityNon-alcoholic Fatty Liver Disease

Interventions

S-Adenosylmethionine

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethionineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAmino AcidsAmino Acids, Peptides, and ProteinsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

April 15, 2005

First Posted

April 18, 2005

Study Start

January 1, 2004

Study Completion

December 1, 2006

Last Updated

January 21, 2009

Record last verified: 2007-05

Locations

US(1)