- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00108589
S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis
January 20, 2009 updated by: US Department of Veterans Affairs
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.
Study Overview
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kentucky
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Louisville, Kentucky, United States, 40206
- VA Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Men with biopsy proven non-alcoholic steatohepatitis from the liver disease clinic or referred from other physicians from the VAMC-Louisville.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion
December 1, 2006
Study Registration Dates
First Submitted
April 15, 2005
First Submitted That Met QC Criteria
April 15, 2005
First Posted (Estimate)
April 18, 2005
Study Record Updates
Last Update Posted (Estimate)
January 21, 2009
Last Update Submitted That Met QC Criteria
January 20, 2009
Last Verified
May 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLIN-014-03S
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatitis
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University of Maryland, BaltimoreAlexandria University; MADAUS GmbH; The Egyptian Company for Blood Transfusion... and other collaboratorsTerminatedAcute Hepatitis C | Acute Hepatitis B | Acute Hepatitis A | Acute Hepatitis E | Acute EBV Hepatitis | Acute CMV HepatitisEgypt
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Gilead SciencesCompletedChronic Hepatitis DeltaFrance, Moldova, Republic of, Romania, Russian Federation
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Ziauddin HospitalUnknown
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National Taiwan University HospitalNational Science Council, Taiwan; National Health Research Institutes, TaiwanUnknownChronic Hepatitis B | Chronic Hepatitis DTaiwan
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Hepatera Ltd.CompletedChronic Hepatitis D Infection
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AbbVieCompletedHepatitis C Virus | Chronic Hepatitis C Virus
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AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States
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AbbVieCompletedChronic Hepatitis C | Hepatitis C (HCV) | Hepatitis C Genotype 1a
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AbbVie (prior sponsor, Abbott)CompletedChronic Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV)United States, Australia, Canada, France, Germany, New Zealand, Puerto Rico, Spain, United Kingdom
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Beijing Kawin Technology Share-Holding Co., Ltd.CompletedChronic Hepatitis cChina
Clinical Trials on S-adenosylmethionine
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Baylor Research InstituteNational Institutes of Health (NIH)CompletedHyperhomocysteinemiaUnited States
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University of California, DavisNational Institute on Alcohol Abuse and Alcoholism (NIAAA); University of Colorado... and other collaboratorsCompleted
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Medical University of WarsawNational Science Centre, PolandRecruitingPrimary Sclerosing Cholangitis (PSC)Poland
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Cedars-Sinai Medical CenterJarrow Formulas IncNot yet recruitingColorectal Cancer | Liver Metastases | Liver Metastasis Colon Cancer | Liver Injury | Sinusoidal Obstruction Syndrome | 5-Fluorouracil Toxicity | Liver Toxicity, Chemically-InducedUnited States
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VA Office of Research and DevelopmentCompleted
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Institute of Liver and Biliary Sciences, IndiaCompletedNon-alcoholic SteatohepatitisIndia
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Shiga UniversityUniversity of Chicago; Shionogi; Tokyo University; Showa University; Fukushima Medical... and other collaboratorsUnknown
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Boston Scientific CorporationCompletedTachycardia, VentricularUnited Kingdom, Denmark, Italy, New Zealand, Germany, France, Netherlands, Portugal, Czechia, Spain
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University Hospital, ToulouseCompleted
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First Affiliated Hospital of Zhejiang UniversityRecruiting