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NCT04250259 · ClinicalTrials.gov registry record · Phase 2
SAMe Trial for Patients With Alcoholic Cirrhosis
A Phase 2 study of Alcoholic Cirrhosis, sponsored by Indiana University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 196
- Enrollment target
- 2
- Study locations
NCT04250259: Recruiting Phase 2 study of Alcoholic Cirrhosis, sponsored by Indiana University.
NCT04250259 is a Phase 2 study of Alcoholic Cirrhosis that is actively recruiting participants, run by Indiana University. The registered enrollment target is 196 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04250259, a Phase 2 study of Alcoholic Cirrhosis, is actively recruiting participants, sponsored by Indiana University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 196 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SAMe 400 mg tablet
Study Locations (2)
California
- Cedars-Sinai Medical Center - Los Angeles
Indiana
- Indiana University Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2020-10-22 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 2 |
What NCT04250259 shows while recruiting
NCT04250259 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher).
The record links to 1 condition, with Alcoholic Cirrhosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04250259 reports a single indexed study location in California, Indiana.
Frequently Asked Questions
What is clinical trial NCT04250259 about?
NCT04250259 is a clinical study titled "SAMe Trial for Patients With Alcoholic Cirrhosis". 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 f...
What is the current status of trial NCT04250259?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 196 participants. The study started on 2020-10-22. Estimated completion is 2027-03-01.
What conditions does trial NCT04250259 study?
This clinical trial studies the following conditions: Alcoholic Cirrhosis.
What interventions are being tested in trial NCT04250259?
The interventions under investigation include: Placebo (DRUG), SAMe 400 mg tablet (DRUG).
Who is sponsoring clinical trial NCT04250259?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04250259 being conducted?
This trial has 2 study locations across California, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04250259's enrollment target sits among peer trials
196 349th of 2000 higher than 1,652 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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