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NCT05639543 · ClinicalTrials.gov registry record · Phase 2
FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study
A Phase 2 study of Alcohol-associated Hepatitis, sponsored by Intercept Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 20
- Study locations
NCT05639543 is a Phase 2 study of Alcohol-associated Hepatitis that is actively recruiting participants, run by Intercept Pharmaceuticals. The registered enrollment target is 80 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT05639543, a Phase 2 study of Alcohol-associated Hepatitis, is actively recruiting participants, sponsored by Intercept Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this trial is to assess dose related safety, efficacy, and pharmacokinetics (PK) of INT-787 in participants with severe alcohol-associated hepatitis (sAH).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG INT-787
Study Locations (20)
Texas
- The Liver Institute at Methodist Dallas Medical Center - Dallas
- Parkland Health and Hospital System - Dallas
- University of Texas Southwestern Medical Center - Dallas
- Baylor College of Medicine - Houston
Florida
- Clinical Translational Research Site - Miami
- Tampa General Medical Group - Tampa
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- UMass Memorial Medical Center - Worcester
New York
- Northwell Health Center for Liver Disease and Transplantation - Manhasset
- Columbia University Medical Center/New York Presbyterian Hospital - New York
California
- Stanford Healthcare - Palo Alto
Illinois
- Rush University Medical Center - Chicago
Maryland
- Mercy Medical Center - Baltimore
Michigan
- Henry Ford Health System - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-12-15 |
| Est. Completion | 2027-04-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05639543
The ClinicalTrials.gov registry entry for NCT05639543 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intercept Pharmaceuticals, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alcohol-associated Hepatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05639543 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Texas, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05639543 about?
NCT05639543 is a clinical study titled "FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study". The purpose of this trial is to assess dose related safety, efficacy, and pharmacokinetics (PK) of INT-787 in participants with severe alcohol-associated hepatitis (sAH).
What is the current status of trial NCT05639543?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2022-12-15. Estimated completion is 2027-04-01.
What conditions does trial NCT05639543 study?
This clinical trial studies the following conditions: Alcohol-associated Hepatitis.
What interventions are being tested in trial NCT05639543?
The interventions under investigation include: Placebo (DRUG), INT-787 (DRUG).
Who is sponsoring clinical trial NCT05639543?
This trial is sponsored by Intercept Pharmaceuticals, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05639543 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.