SAMe Trial for Patients With Alcoholic Cirrhosis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIndiana University

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

196 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Indiana University

Lead sponsor

Cedars-Sinai Medical Center

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator