Status:
COMPLETED
Randomized, Controlled Trial of S-adenosylmethionine in Alcoholic Liver Disease
Lead Sponsor:
Loma Linda University
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Alcoholic Hepatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Background: Alcoholic liver disease is one of the most important causes of chronic liver disease in this country. There is currently no treatment for chronic alcoholic liver disease other than abstine...
Detailed Description
Methods: This is a randomized, double blind, placebo-controlled trial. Thirty patients with stable alcoholic hepatitis (Maddrey Score \< 32) without cirrhosis who meet entry criteria will receive eith...
Eligibility Criteria
Inclusion
- Patients must be chronic alcohol users, defined by a history of ethanol consumption on average \> 40g/day for women and 60g/day for men for at least 1 year before inclusion.
- The presumptive diagnosis for alcoholic hepatitis will be: recent binge drinking; compatible physical findings (one or more: jaundice, enlarged liver, hepatic bruit, abdominal pain, loss of appetite, nausea); and a compatible biochemical profile (moderate elevation of AST over ALT, elevated total serum bilirubin); or a liver-spleen colloid scan suggestive of reticulo-endothelial redistribution and hepatic arterialization.
- The diagnosis of alcoholic hepatitis must be confirmed on liver biopsy, showing typical features of acute sclerosing hyaline necrosis 70.
- The degree of portal fibrosis as determined on liver biopsy, graded according to the Knodell score-modified by Ishak 71 must be less than or equal to 5 out of a possible score of 6, 6 indicating cirrhosis.
- The alcoholic hepatitis must be "stable", i.e. not requiring treatment by either pentoxifylline 72 or prednisone, with a Maddrey Score 73 {(PTpatient - PTcontrol) x 4.6 + TBmg/dL} \< 32.
- Patients must be willing to participate in the trial, remain abstinent to alcohol, and compliant to the treatment regimen, and undergo a post-treatment liver biopsy.
Exclusion
- Patients who have either compensated cirrhosis (biopsy proven) or a clinical picture of severe cirrhosis defined as Child's class C and/or with a recent history (within one month) of decompensated liver disease (history of ascites, encephalopathy or variceal bleeding within one month of trial entry). These patients have reduced life expectancy below one year and are most often severely coagulopathic and cannot be biopsied.
- Patients who have severe acute alcoholic hepatitis of poor prognosis defined as a Maddrey Score \> 32. These patients have a mortality rate of 50% during their hospitalization period when untreated by either prednisone or pentoxifylline.
- Patients who are receiving hepatotropic treatments such as colchicine, penicillamine, corticosteroids, ursodeoxycholic acid, and pentoxifylline.
- Patients who are receiving known hepatotoxic long-term treatments such as NSAIDs, statins, neuroleptics, certain anti-convulsive medications, or high-dose acetaminophen.
- Patients suspected of having hepatocellular carcinoma.
- Patients who have contra-indications to liver biopsy.
- Patients who have a liver biopsy that does not yield sufficient specimen for analyses.
- Patients who have untreated deficiencies of folic acid, vitamin B6 or B12.
- Patients who have chronic active Hepatitis B or C, hemochromatosis, autoimmune hepatitis, or a cholangiopathy.
- Patients with psychotic disorders, and in particular manic depression (contra indication to SAMe treatment).
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00851981
Start Date
October 1 2008
End Date
May 1 2010
Last Update
September 13 2010
Active Locations (1)
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1
Loma Linda University
Loma Linda, California, United States, 92354