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

OverviewStructured DataIssuesContributors
Is a
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Clinical study
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Allocation Type
Randomized
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Participating Facility
Mayo Clinic
Mayo Clinic
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Hospital of the University of Pennsylvania
Hospital of the University of Pennsylvania
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Henry Ford Health System
Henry Ford Health System
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Rush University Medical Center
Rush University Medical Center
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Medical University of South Carolina
Medical University of South Carolina
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Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
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‌
Mercy Medical Center
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Imperial College Healthcare NHS Trust
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Intervention Model
Single Group Assignment
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Intervention Name
Placebo
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INT-787
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Interventional Trial Phase
Phase 2
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Interventional Trial Purpose
Treatment
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Intervention Type
Drug
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Last Updated
December 27, 2023
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Masked Party
Participant
0
Care Provider
0
Investigator
0
Masking Type
Triple
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Primary Completion Date
December 31, 2024
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Trial Recruitment Size
50
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Trial Sponsor
Intercept Pharmaceuticals
Intercept Pharmaceuticals
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Clinical Trial Start Date
December 15, 2022
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Study Completion Date
December 31, 2024
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Clinical Trial Study Type
Interventional
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NCT Number
NCT05639543
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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 Hepatitis
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Official Website
clinicaltrials.gov/study...639543
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