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RECRUITING
NCT05639543
PHASE2

FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study

Sponsor: Intercept Pharmaceuticals

View on ClinicalTrials.gov

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

80

Start Date

2022-12-15

Completion Date

2027-04-01

Last Updated

2025-04-13

Healthy Volunteers

No

Interventions

DRUG

INT-787

Blinded Study Drug

DRUG

Placebo

Placebo

Locations (31)

Stanford Healthcare

Palo Alto, 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

Rutgers-New Jersey Medical School

Newark, New Jersey, 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

Parkland Health and Hospital System

Dallas, Texas, United States

University of Texas Southwestern 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, 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

King's College Hospital

London, United Kingdom

University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom