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Placebo

SAMe for Liver Cirrhosis

Phase 2
Recruiting
Led By Suthat Liangpunsakul, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
subjects are healthy without underlying acute or chronic medical conditions.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 months
Awards & highlights

Study Summary

This trial will test whether SAMe supplements can improve liver function in patients with alcoholic cirrhosis, which may lead to reduced all-cause mortality.

Who is the study for?
This trial is for adults aged 18-70 with alcoholic cirrhosis in Child Class A or B, who have been heavy drinkers but are now sober for at least 3 months. They must be generally healthy without serious illnesses like heart failure or infections and not on certain medications that affect SAMe's action.Check my eligibility
What is being tested?
The study tests if a supplement called SAMe can improve liver function in patients with alcoholic cirrhosis compared to a placebo. Participants will randomly receive either the SAMe tablets or placebo, and researchers will monitor their liver health and overall survival.See study design
What are the potential side effects?
While specific side effects of SAMe aren't detailed here, it may interact with psychiatric medications. Commonly reported side effects from other sources include digestive discomfort, dry mouth, headache, mild insomnia, and anxiety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am healthy with no serious long-term or sudden illnesses.
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I have cirrhosis confirmed by tests or biopsy and my condition is moderately severe.
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I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
SAMe supplement's effect on all-cause mortality
Secondary outcome measures
SAMe supplement's effect on cellular oxidative stress and/or endoplasmic reticulum (ER) stress, as defined by mitochondrial DNA
SAMe supplement's effect on infections of the liver
SAMe supplement's effect on intestinal permeability function, as defined by serum lipopolysaccharides (LPS)
+6 more
Other outcome measures
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).

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: 1,200 mg SAMeExperimental Treatment1 Intervention
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
Group II: Non-drinking ControlsActive Control1 Intervention
Non-drinking healthy controls
Group III: PlaceboPlacebo Group1 Intervention
Alcoholic Cirrhosis on placebo

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
977 Previous Clinical Trials
983,117 Total Patients Enrolled
Cedars-Sinai Medical CenterOTHER
497 Previous Clinical Trials
164,363 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
796 Previous Clinical Trials
1,361,227 Total Patients Enrolled

Media Library

Placebo (Placebo) Clinical Trial Eligibility Overview. Trial Name: NCT04250259 — Phase 2
Cirrhosis Research Study Groups: Placebo, 1,200 mg SAMe, Non-drinking Controls
Cirrhosis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04250259 — Phase 2
Placebo (Placebo) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04250259 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation accommodating those older than 35 years of age?

"This trial is only open to patients between 18 and 70 years old. 76 clinical trials are available for those below the age of consent, while an additional 413 studies target patients over 65."

Answered by AI

Are new participants being enrolled in this trial right now?

"Affirmative. The details on clinicaltrials.gov validate that this experiment is searching for participants, which was first posted on September 1st 2020 and recently updated December 10th 2021. A total of 196 patients from one centre are being sought out by the trial team."

Answered by AI

Are there any particular individuals who are best suited for involvement in this clinical experiment?

"To be eligible for this research, patients must have cirrhosis caused by alcohol abuse and fall between 18-70 years of age. The trial is aiming to recruit 196 participants in total."

Answered by AI

What is the upper limit for participants in this research?

"That is correct. The clinical trial data hosted on clinicaltrials.gov suggests that this study, which was posted for the first time in September 2020, is currently recruiting participants. There are 196 individuals needed to be registered from a single medical facility."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Indiana University Hospital
Cedars-Sinai Medical Center
How many prior treatments have patients received?
0
3+
~57 spots leftby Sep 2025