About this trial
The proposed of this randomized, double blinded, placebo-controlled study is to assess the effect of SAMe compared to placebo in patients with alcoholic cirrhosis Child Class A and B. The primary objective of the study is to test relationship between SAMe (S-adenosylmethionine) supplement on liver function. The hypothesis is that SAMe supplement will improve liver function in patients with alcoholic liver disease. The improvement in liver function will lead to the reduction in all-cause mortality in patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo.
Eligibility criteria
Qualifiers
Evidence of cirrhosis as per clinical signs and/or noninvasive transient elastography (Fibroscan®), computed tomography, magnetic resonance imaging including MRI elastography compatible with cirrhosis and/or histopathology by biopsy and
subjects with clinical presentation either in Child Class A or B at the time of enrollment
individuals 18 to 70 years old and may or may not consume alcohol during study.
Disqualifiers
Active infection as evidenced by positive urine culture, blood culture, or pneumonia,
Known co-existing infection with hepatitis C, hepatitis B, or HIV
Significant systemic or major illness including chronic obstructive pulmonary disease, congestive heart failure, and renal failure that in the opinion of the Investigator would preclude the patient from participating in and completing the study
Gastrointestinal bleeding within the prior 28 days3
Trial design
Treatments tested in this trial
- Placebo
- SAMe 400 mg tablet
Treatment groups
Sponsors and collaborators
Indiana University
Lead sponsor
Cedars-Sinai Medical Center
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator