Clinical Trial

SAMe Trial for Patients With Alcoholic Cirrhosis

Recruiting Phase 2
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Summary
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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2020-01-29; most recent amendment 2026-03-26.
Status change: Not Yet Recruiting → Recruiting 2021-08-23
Trial Details
NCT Number NCT04250259
Lead Sponsor Indiana University
Collaborators: Cedars-Sinai Medical Center, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions Alcoholic Cirrhosis
Enrollment 196 participants
Start Date 2020-10-22
Primary Completion 2027-03-01 (estimated)
Study Completion 2027-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-31