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

OverviewStructured DataIssuesContributors

Contents

clinicaltrials.gov/study/NCT05639543
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT056395430
Trial Recruitment Size
500
Trial Sponsor
Intercept Pharmaceuticals
Intercept Pharmaceuticals
0
Clinical Trial Start Date
December 15, 2022
0
Primary Completion Date
December 31, 2024
0
Study Completion Date
December 31, 2024
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Intervention Name
Placebo0
INT-7870
Interventional Trial Phase
Phase 20
Participating Facility
Mayo Clinic
Mayo Clinic
0
Hospital of the University of Pennsylvania
Hospital of the University of Pennsylvania
0
Henry Ford Health System
Henry Ford Health System
0
Rush University Medical Center
Rush University Medical Center
0
Medical University of South Carolina
Medical University of South Carolina
0
Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
0
‌
Mercy Medical Center
0
‌
Imperial College Healthcare NHS Trust
0
Official Name
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 Hepatitis0
Last Updated
December 27, 2023
0
Allocation Type
Randomized0
Intervention Model
Single Group Assignment0
Masking Type
Triple0
Masked Party
Participant0
Care Provider0
Investigator0
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).

Timeline

No Timeline data yet.

Further Resources

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