SAMe Trial for Patients With Alcoholic Cirrhosis

ConditionAlcoholic Cirrhosis

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-70

SponsorIndiana University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

196 Participants

are divided into 3 treatment groups

Group A: PlaceboPlacebo comparator 1 intervention

Group B: 1,200 mg SAMeExperimental treatment 1 intervention

Group C: Non-drinking ControlsNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

Baseline to end of 24 months

Secondary outcomes

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

The function of intestinal permeability will be evaluated by testing serum lipopolysaccharides (LPS) in patients who receive SAMe compared to those who receive placebo. Lipopolysaccharides (LPS) are large molecules consisting of a lipid and a polysaccharide that are bacterial toxins.

Time frame

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

Cellular oxidative stress and/or endoplasmic reticulum (ER) stress will be evaluated by measuring the levels of mitochondrial DNA in the blood of patients who receive SAMe compared to those who receive placebo.

Time frame

baseline to 24 months

SAMe supplement's effect on liver deuteriation

determining Proportion of subjects undergoing liver transplantation in patients who receive SAMe compared to those who receive placebo

Time frame

baseline to 24 months

SAMe supplement's effect on liver developing cancer

Proportion of subjects developing new onset hepatocellular carcinoma in patients who receive SAMe compared to those who receive placebo

Time frame

baseline to 24 months

Other outcomes

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).

The metabolic profiling of the serum and urine will be collected by those in the study who received the SAMe supplement and will be used as the surrogates for this prediction.

Time frame

baseline to 24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Cedars-Sinai Medical Center

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov

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