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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 is a Phase 2 study of Alcoholic Cirrhosis that is actively recruiting participants, run by Indiana University. The registered enrollment target is 196 participants. The trial reports 2 study locations across 2 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04250259
The ClinicalTrials.gov registry entry for NCT04250259 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 196 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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