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New treatment option for Alcoholic Cirrhosis
Official title SAMe Trial for Patients With Alcoholic Cirrhosis
ClinicalTrials.gov ID: NCT04250259
What this study is testing
What is SAMe 400 mg tablet?
SAMe 400 mg tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for alcoholic cirrhosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- for patients with alcoholic cirrhosis
- Evidence of cirrhosis as per clinical signs and/or noninvasive transient elastography (Fibroscan®), computed tomography, magnetic resonance imaging...
- people 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. for healthy control : ) individuals 18 to 70 years old (2) able to...
You likely can't join if
- 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...
- Gastrointestinal bleeding within the prior 28 days3
- Participation in another investigational drug, biologic, or medical device trial within 30 days prior to screening
See the full eligibility 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...
- people 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. for healthy control : ) individuals 18 to 70 years old (2) able to provide informed consent (3) people do not consume any alcohol or those...
- 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...
- 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
- people 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 assigned by chance controlled trials4. We acknowledge that if we assign family members to identical...
- people with psychiatric illnesses such as bipolar disorders as SAMe may interfere with the levels of anti-psychotic drugs and
- people who are immunocompromised Exclusion criteria for all healthy control participants:
- people with an active and serious medical disease
- people with an infectious disease
- consume any alcohol within 3 months before the study
- people with localized or systemic infection
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Indianapolis, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.