Cohort/Ethics Study of Patients With Severe Alcoholic Hepatitis Undergoing Early Liver Transplantation
Launched by JOHNS HOPKINS UNIVERSITY · Jan 17, 2020
Trial Information
Current as of November 11, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This is an observational study at Johns Hopkins to learn more about early liver transplantation for people with severe alcoholic hepatitis (SAH) and to compare their outcomes with people transplanted for alcoholic liver disease (ALD). Researchers want to see how many patients survive the first year after transplant and whether they relapse into drinking within that year. They also plan to gather opinions from doctors, patients, and the public to help build an ethical framework for offering transplants to SAH patients.
Who may be eligible? Adults 18 and older listed for liver transplantation at Johns Hopkins with SAH who have not been sober for at least 6 months before waitlisting. A comparison group includes adults undergoing liver transplantation for ALD who have been sober for at least 6 months. This is not a randomized trial; it uses ongoing and past patient data (retrospective and prospective cohorts). Participants receive standard transplant care, and researchers will track outcomes such as 1-year survival and any alcohol relapse. The study is overseen by a data safety/monitoring committee, does not involve drugs or devices, and will not publicly share individual patient data. The study started in 2020 and aims to complete by the end of 2025.
Gender
ALL
Eligibility criteria
- Inclusion Criteria for Severe Alcoholic Hepatitis patients:
- • Patients with Severe Alcoholic Hepatitis (SAH) listed for liver transplantation at Johns Hopkins Hospital (JHH), have not been sober for at least 6 months at time of waitlisting, and are at least 18 years old.
- Exclusion Criteria for Severe Alcoholic Hepatitis patients:
- • Non-SAH patients listed for liver transplantation at JHH and patients who have been sober for at least 6 months at the time of waitlisting.
- Inclusion Criteria for non-SAH comparison group:
- • Patients 18 years or older undergoing liver transplantation at JHH for alcoholic liver disease and were sober for at least 6 months prior to transplantation.
- Exclusion Criteria for non-SAH comparison group:
- • Patients who do not meet inclusion criteria.
About Johns Hopkins University
Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Baltimore, Maryland, United States
Patients applied
Trial Officials
Andrew M Cameron, MD, PhD
Principal Investigator
Johns Hopkins University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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