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SAMe Trial for Patients With Alcoholic Cirrhosis

StatusRecruiting
PhasePhase 2
Started2020-10-22
View on ClinicalTrials.gov ↗

Amendment history

2026-03-26
Study Status, Contacts/Locations v11
Study sitescontacts updated at 1 of 2 sites
2025-10-01
Study Status v10
Primary completion date2025-09-01→2027-03-01
Completion date2025-09-01→2027-03-01
2025-08-22
Study Identification, Study Status, Contacts/Locations v9
Study sitescontacts updated at 2 of 2 sites
Study titlerevised
SAMe Trial for Patients withWith Alcoholic Cirrhosis
2024-11-12
Study Identification, Study Status, Contacts/Locations v8
Study sitescontacts updated at 2 of 2 sites
Study titlerevised
SAMe Trial for Patients Withwith Alcoholic Cirrhosis
2023-10-02
Study Status, Outcome Measures, Eligibility v7
Eligibility criteria-145 characters
[...] tion 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. 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 [...] n average in women and < 80 grams per day on average in men and(4) do not consume any alcohol within 3 months before the study and subjects are healthy without underlying acute or chronic med [...] ced by positive urine culture, blood culture, or pneumonia, Serum creatinine >1.5 mg/dl Known [...] [...]
Secondary endpoints12 to 9 entries
SAMe supplement's effect on overall liver health, as defined by MELD Scores SAMe supplement's effect on liver fibrosis SAMe supplement's effect on overall liver health, as defined by Child-Pugh Scores
Show 6 earlier versions
2023-04-03
Study Status, Oversight, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v6
PhaseNot applicable→Phase 2
Primary completion date2024-09-01→2025-09-01
Study sites1→2
InterventionsPlacebo (Dietary Supplement), SAMe 400 mg tablet (Dietary Supplement)→Placebo (Drug), SAMe 400 mg tablet (Drug)
Secondary endpoints12 entries, revised
Dietary SAMe supplement's actseffect to maintainon intestinal permeability function, as defined by serum lipopolysaccharides (LPS) Dietary SAMe supplement's actseffect to maintain or improve the levels ofon cellular oxidative stress and/or endoplasmic reticulum (ER) stress, as defined by mitochondrial DNA SAMe supplement's effect on overall liver health, as defined by MELD Scores SAMe supplement's effect on liver fibrosis using FibroScan testing,a non-invasive diagnostic device used to measure liver scarring or fibrosis caused by a number of liver diseases. SAMe supplement's effect on overall [...] [...]
Primary endpoints1 entry, revised
Measure the mortality of patients with alcoholic cirrhosis in those who receive SAMe supplement's wheneffect comparedon toall-cause those receiving placebomortality
2023-03-02
Study Identification, Study Status, Sponsor/Collaborators, Outcome Measures, Eligibility, Contacts/Locations v5
Start date2020-09-01→2020-10-22
Eligibility criteria-472 characters
Inclusion criteria for patients with alcoholic cirrhosis Patients must have had alcohol consumption averaging at least 80 grams per day (for men) or 50 grams per day (for women), for at least 10 years. These criteria are based on epidemiological evidence of the alcohol-cirrhosis relationship. The cutoff was set at a relatively high level so as to minimize [...] Evidence of cirrhosis as per clinical signs and/or noninvasi [...] e may interfere with the levels of anti-psychotic drugs and Systemic antibiotic use or use of rifaximin for 10 days or more in last 2 months before the enrollment. Exclusion criteria [...]
Secondary endpoints+969 characters
Dietary SAMe supplement acts to maintain intestinal permeability function Dietary SAMe supplement acts to maintain or improve the levels of cellular oxidative stress and/or endoplasmic reticulum (ER) stress SAMe supplement's effect on liver deuteriation SAMe supplement's effect on liver developing c [...]
Study sitescontacts updated at 1 of 1 site
Collaborators+86 characters
Cedars-Sinai Medical Center National Institute on Alcohol Abuse and Alcoholism (NIAAA)
2021-12-10
Study Status, Contacts/Locations v4
Re-verified, no change to tracked fields
2021-08-27
Study Status, Study Design v3
Primary completion date2025-03-01→2024-09-01
Completion date2030-03-01→2025-09-01
Start date2020-03-01→2020-09-01
2021-08-23
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2020-03-06
Study Status v1
Re-verified, no change to tracked fields
2020-01-29
Original filing
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.
Trial Details
NCT Number NCT04250259
Lead Sponsor Indiana University
Collaborators: Cedars-Sinai Medical Center, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions Alcoholic Cirrhosis
Enrollment 196 participants
Start Date 2020-10-22
Primary Completion 2027-03-01 (estimated)
Study Completion 2027-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-31