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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04234139

Enrollment

300

Registered

2020-01-21

Start date

2020-04-01

Completion date

2029-12-31

Last updated

2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol-Induced Disorders, Alcohol-Related Disorders, Hepatitis, Alcoholic, Liver Diseases, Liver Diseases, Alcoholic, Transplant; Complication, Rejection, Transplant; Failure, Liver

Keywords

liver transplant, alcoholic liver disease

Brief summary

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.

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.

Interventions

PROCEDUREliver transplant

solid organ transplant

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026