SAMe Trial for Patients With Alcoholic Cirrhosis

NCT04250259 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: SAMe Trial5U01AA026817-04
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Child Class A or B

Outcome Measures

Primary Outcomes (1)

• SAMe supplement's effect on all-cause mortality

  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.

  Baseline to end of 24 months

Secondary Outcomes (9)

• SAMe supplement's effect on intestinal permeability function, as defined by serum lipopolysaccharides (LPS)

  baseline to end of 24 months

• SAMe supplement's effect on cellular oxidative stress and/or endoplasmic reticulum (ER) stress, as defined by mitochondrial DNA

  baseline to 24 months

• SAMe supplement's effect on liver deuteriation

  baseline to 24 months

• SAMe supplement's effect on liver developing cancer

  baseline to 24 months

• SAMe supplement's effect on infections of the liver

  baseline to 24 months

Other Outcomes (1)

• Exploratory outcome - identify who will improve their liver functions by taking the SAMe supplement amongst those that have been diagnosed with alcoholic cirrhosis (Child-Pugh score of A or B).

  baseline to 24 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Alcoholic Cirrhosis on placebo

Drug: Placebo

1,200 mg SAMe

EXPERIMENTAL

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

Drug: SAMe 400 mg tablet

Non-drinking Controls

NO INTERVENTION

Non-drinking healthy controls

Interventions

Placebo DRUG

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

Placebo

SAMe 400 mg tablet DRUG

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

1,200 mg SAMe

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ) individuals 18 to 70 years old (2) able to provide informed consent (3) subjects do not consume any alcohol or those who drink \< 50 grams per day on average in women and \< 80 grams per day on average in men (4) subjects are healthy without underlying acute or chronic medical conditions.

You may not qualify if:

• 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
• Participation in another investigational drug, biologic, or medical device trial within 30 days prior to screening
• Women who are pregnant, may become pregnant, or nursing
• Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of SAMe such as those with gastric bypass surgery
• Subjects with history of/diagnosis of hepatocellular carcinoma
• Members from the same family of study participant. This is based on the recent paper on the non-random sampling in randomized controlled trials4. We acknowledge that if we assign family members to identical treatment, randomization would not be totally correct; but if properly randomized, there is a chance that the members of the family might mix the pills. To avoid this issue and maintain the integrity of randomized blinded fashion, we will not include members from the same family into the study
• Subjects with psychiatric illnesses such as bipolar disorders as SAMe may interfere with the levels of anti-psychotic drugs and
• Subjects who are immunocompromised
• subjects with an active and serious medical disease
• subjects with an infectious disease
• consume any alcohol within 3 months before the study
• subjects with localized or systemic infection

Sponsors & Collaborators

• Cedars-Sinai Medical Center: collaborator
• Indiana University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis, Alcoholic

Interventions

S-Adenosylmethionine; Tablets

Condition Hierarchy (Ancestors)

Liver Cirrhosis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Suthat Liangpunsakul, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maggie Hesler, B.S

CONTACT

(317) 988-4545; mshesler@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 31, 2020
• Study Start: October 22, 2020
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (2)