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FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study
Sponsor: Intercept Pharmaceuticals
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).
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation, Proof-of-Concept Study Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics of INT-787 in Subjects With Severe Alcohol Associated Hepatitis
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
67
Start Date
2022-12-15
Completion Date
2026-02-10
Last Updated
2026-05-05
Healthy Volunteers
No
Conditions
Interventions
INT-787
Blinded Study Drug
Placebo
Placebo
Locations (29)
University of California, San Francisco-Fresno
Fresno, California, United States
Stanford Healthcare
Palo Alto, California, United States
UC Davis Medical Center
Sacramento, California, United States
Clinical Translational Research Site
Miami, Florida, United States
Tampa General Medical Group
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Mercy Medical Center
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Northwell Health Center for Liver Disease and Transplantation
Manhasset, New York, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt Digestive Disease Center
Nashville, Tennessee, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
VCU Health Clinical Research Services Unit
Richmond, Virginia, United States
CHU Angers
Angers, France
Hopital Beaujon
Clichy, France
Hopital Claude Huriez
Lille, France
Hopital Pitie Salpetriere
Paris, France
Hopital Rangueil
Toulouse, France
Cambridge University NHS Foundation Trust
Cambridge, United Kingdom
Royal Free Hospital
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom