NCT04250259

SAMe Trial for Patients With Alcoholic Cirrhosis

A Multi-center, Randomized, Placebo-controlled Trial of S-Adenosylmethionine (SAMe) in Patients With Alcoholic Cirrhosis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-10-22
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2020-01-31
• Last updated: 2026-03-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study