Cohort/Ethics Study of Patients With Severe Alcoholic Hepatitis Undergoing Early Liver Transplantation

December 15, 2025 updated by: Johns Hopkins University
The purpose of this study is to develop a clinical understanding of early liver transplantation (ELT) for patients with severe alcoholic hepatitis (SAH) and identify the public's opinion regarding this practice.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The research study is designed to improve the investigators' understanding of early liver transplantation for patients with severe alcoholic hepatitis. The goal of this research is twofold:

  1. Establish a knowledge base necessary for appropriate liver transplant candidate selection by quantifying post-ELT mortality for SAH and compare to outcomes to liver transplantation for other indications
  2. Develop an ethical framework for implementation of these transplants for SAH based on the opinions of healthcare providers and the general public.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Severe Alcoholic Hepatitis patients listed for liver transplatation at Johns Hopkins Hospital and patients undergoing liver transplantation at Johns Hopkins Hospital for Alcoholic Liver Disease

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective Cohort
Early Liver Transplantation (ELT) for patients who presented with Severe Alcoholic Hepatitis (SAH)
Procedure: liver transplant
solid organ transplant
Prospective Cohort 1
Early Liver Transplantation (ELT) for patients who present with Severe Alcoholic Hepatitis (SAH)
Procedure: liver transplant
solid organ transplant
Prospective Cohort 2
Orthotopic Liver Transplantation (OLT) in patient who present with Alcoholic Liver Disease (ALD)
Procedure: liver transplant
solid organ transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who survived within 1 year post-transplant
Time Frame: 1 years
Post-transplant survival within one year of the surgical procedure.
1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who self-report or have biochemically measured alcohol recidivism or relapse within 1 year post-transplant
Time Frame: 1 years
Self-reported or biochemically measured alcohol recidivism or relapse.
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Andrew M Cameron, MD, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 21, 2020

Study Record Updates

Last Update Posted (Estimated)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00154881
  • P50AA027054 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe