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 (INT787-201)
The FRESH Study FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH)
Sponsor: Intercept Pharmaceuticals, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAV2701
U.S. Govt. ID: NCT05639543
Contact: Thresiamma Lukose: 212-305-7482 / tcrcstudyreferral@cumc.columbia.edu
Additional Study Information: The purpose of this study is to determine if an experimental drug, INT-787, is safe and effective in patients who are hospitalized due to severe alcohol-associated hepatitis. This is a double-blind study, so the study doctors and participants will not know if they are receiving INT-787 or a placebo. Participation will last approximately 3 months. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC)
Investigator
Elizabeth Verna, MD
Do You Qualify?
Are between the ages of 18 and 65 years old? Yes No
Have you been diagnoses with alcoholic hepatitis? Yes No
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For more information, please contact:
Thresiamma Lukose
tcrcstudyreferral@cumc.columbia.edu
212-305-7482