RecruitingPhase 2NCT04250259

SAMe Trial for Patients With Alcoholic Cirrhosis

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

Sponsor

Indiana University

Enrollment

196 participants

Start Date

Oct 22, 2020

Study Type

INTERVENTIONAL

Conditions

Alcoholic Cirrhosis

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

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.

Exclusion Criteria15

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

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Interventions

DRUGPlacebo

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

DRUGSAMe 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