SAMe Trial for Patients With Alcoholic Cirrhosis

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• SAMe supplement's effect on all-cause mortality [Срок оценки: Baseline to end of 24 months]

Вторичные конечные точки (9)

• SAMe supplement's effect on intestinal permeability function, as defined by serum lipopolysaccharides (LPS) [Срок оценки: 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 [Срок оценки: baseline to 24 months]
• SAMe supplement's effect on liver deuteriation [Срок оценки: baseline to 24 months]
• SAMe supplement's effect on liver developing cancer [Срок оценки: baseline to 24 months]
• SAMe supplement's effect on infections of the liver [Срок оценки: baseline to 24 months]
• SAMe supplement's effect on other parts of the body [Срок оценки: baseline to 24 months]
• SAMe supplement's effects on intestinal permeability function, as defined by soluble(s) CD14 [Срок оценки: baseline to 24 months]
• SAMe supplement's effects on intestinal permeability function, as defined by soluble(s) CD163 [Срок оценки: baseline to 24 months]
• SAMe supplement's effects on cellular oxidative stress and/or endoplasmic reticulum (ER) stress, as defined by cytochrome P450 2E1 levels [Срок оценки: baseline to 24 months]

Критерии участия

Inclusion criteria for patients with alcoholic cirrhosis

• 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.

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

• 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

Exclusion criteria for all healthy control participants:

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• Cedars-Sinai Medical Center — Los Angeles
• Indiana University Hospital — Indianapolis

Идентификаторы

NCT: NCT04250259 · SAMe Trial · 5U01AA026817-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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