RE-AHFIRM (RandomizEd study of larsucosterol in Alcohol-associated Hepatitis to confirm saFety and effIcacy of tReatMent)
Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)
Sponsor: Bausch Health Americas, Inc.
Enrolling: Male and Female Patients
IRB Number: ACYY2216
U.S. Govt. ID: NCT07428538
Contact: Transplant Clinical Research Center: 212-305-3839 / tcrcstudyreferral@cumc.columbia.edu
Additional Study Information: Researchers at Columbia University Irving Medical Center are studying whether an investigational medication called larsucosterol, when added to standard medical care, may improve outcomes for people with severe alcohol-associated hepatitis. Alcohol-associated hepatitis is a serious inflammation of the liver caused by heavy alcohol use and can lead to liver failure and other complications. Participants in this study will be randomly assigned (like flipping a coin) to receive either larsucosterol or placebo, in addition to standard medical care; receive study-related evaluations and follow-up visits over approximately 90 days; be asked to participate in an alcohol abstinence support program as part of their care. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
Investigator
Gene Im, MD, FAASLD
Do You Qualify?
Are 18 years of age or older? Yes No
Are currently hospitalized with a diagnosis of alcohol-associated hepatitis? Yes No
Have you recently developed jaundice (yellowing of the skin or eyes) within the past 8 weeks? Yes No
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For more information, please contact:
Transplant Clinical Research Center
tcrcstudyreferral@cumc.columbia.edu
212-305-3839