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Enrolling by Invitation

NCT Number: NCT04234139

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

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.

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Key information

Conditions

Liver Diseases, Alcoholic Alcohol-Induced Disorders Alcohol-Related Disorders Behavior Chemically-Induced Disorders Digestive System Diseases Hepatitis Hepatitis, Alcoholic Liver Diseases Mental Disorders Rejection, Psychology Social Behavior Substance-Related Disorders Transplant; Complication, Rejection Transplant; Failure, Liver

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

About this study

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:

  • 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
  • Develop an ethical framework for implementation of these transplants for SAH based on the opinions of healthcare providers and the general public.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liver transplant

Procedure

solid organ transplant

Primary outcomes

  1. Number of participants who survived within 1 year post-transplant

    Time frame: 1 years

    Post-transplant survival within one year of the surgical procedure.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2020
Primary completion
2028
Study completion
2029
First posted
Jan 21, 2020
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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