Actively Recruiting
SAMe Trial for Patients With Alcoholic Cirrhosis
Led by Indiana University · Updated on 2026-03-31
196
Participants Needed
2
Research Sites
331 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
C
Cedars-Sinai Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
SAMe Trial for Patients With Alcoholic Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Evidence of cirrhosis by clinical signs, imaging (Fibroscan, CT, MRI including MRI elastography), or biopsy
- Clinical presentation in Child Class A or B at enrollment
- Age between 18 and 70 years old
- May or may not consume alcohol during the study
- Healthy controls must be 18 to 70 years old
- Healthy controls able to provide informed consent
- Healthy controls do not consume alcohol or drink less than 50 grams/day (women) or 80 grams/day (men)
- Healthy controls have no acute or chronic medical conditions
You will not qualify if you...
- Active infection confirmed by positive urine culture, blood culture, or pneumonia
- Known infection with hepatitis B, hepatitis C, or HIV
- Significant systemic illness such as COPD, congestive heart failure, or renal failure that would prevent study participation
- Gastrointestinal bleeding within the last 28 days
- Participation in another investigational trial within 30 days before screening
- Women who are pregnant, may become pregnant, or nursing
- Conditions affecting SAMe absorption, distribution, metabolism, or excretion, such as gastric bypass surgery
- History or diagnosis of hepatocellular carcinoma
- Family members of current study participants
- Psychiatric illnesses like bipolar disorder
- Immunocompromised status
- Healthy controls with active or serious medical disease
- Healthy controls with infectious disease
- Healthy controls who consumed alcohol within 3 months before the study
- Healthy controls with local or systemic infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
M
Maggie Hesler, B.S
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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