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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: Recruiting Phase 2 study of Alcohol-associated Hepatitis, sponsored by Intercept Pharmaceuticals.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The Lille score response rate will be analyzed as a categorical variable. Participants with Lille score \<0.45 will be counted as responders and those with Lille score ≥0.45 will be counted as non-responders.
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 |
What NCT05639543 shows while recruiting
NCT05639543 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Alcohol-associated Hepatitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05639543's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 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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