SAMe Trial for Patients with Alcoholic Cirrhosis

Indiana University

Status and phase: Enrolling; Phase 2

Conditions: Alcoholic Cirrhosis

Treatments: Drug: Placebo; Drug: SAMe 400 mg tablet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04250259

SAMe Trial

5U01AA026817-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Enrollment: 196 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for patients with alcoholic cirrhosis

1. 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
2. subjects with clinical presentation either in Child Class A or B at the time of enrollment
3. individuals 18 to 70 years old and may or may not consume alcohol during study.

Inclusion criteria for healthy control :

) 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 criteria for patients with alcoholic cirrhosis

1. Active infection as evidenced by positive urine culture, blood culture, or pneumonia,
2. Known co-existing infection with hepatitis C, hepatitis B, or HIV
3. 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
4. Gastrointestinal bleeding within the prior 28 days3
5. Participation in another investigational drug, biologic, or medical device trial within 30 days prior to screening
6. Women who are pregnant, may become pregnant, or nursing
7. 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
8. Subjects with history of/diagnosis of hepatocellular carcinoma
9. 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
10. Subjects with psychiatric illnesses such as bipolar disorders as SAMe may interfere with the levels of anti-psychotic drugs and
11. Subjects who are immunocompromised

Exclusion criteria for all healthy control participants:

1. subjects with an active and serious medical disease
2. subjects with an infectious disease
3. consume any alcohol within 3 months before the study
4. subjects with localized or systemic infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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196 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Alcoholic Cirrhosis on placebo

Treatment:

Drug: Placebo

1,200 mg SAMe

Experimental group

Description:

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

Treatment:

Drug: SAMe 400 mg tablet

Non-drinking Controls

No Intervention group

Description:

Non-drinking healthy controls