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SAMe Trial for Patients With Alcoholic Cirrhosis

NCT04250259 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2026-03-31

No results posted yet for this study

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.

Conditions

  • Alcoholic Cirrhosis

Interventions

DRUG

Placebo

2 tablets of placebo in the morning before breakfast and one tablet of placebo in the evening before dinner for 24 months

DRUG

SAMe 400 mg tablet

SAMe supplement (SAMe 400 mg tablet), 2 tablets in the morning before breakfast and one tablet in the evening before dinner (a total dose of 1,200 mg daily) for 24 months

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    collaborator OTHER

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Indiana University

    lead OTHER

Principal Investigators

  • Suthat Liangpunsakul, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-22
Primary Completion
2027-03-01
Completion
2027-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04250259 on ClinicalTrials.gov