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

NCT ID: NCT04234139

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2029-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Retrospective Cohort

Early Liver Transplantation (ELT) for patients who presented with Severe Alcoholic Hepatitis (SAH)

liver transplant

Intervention Type PROCEDURE

solid organ transplant

Prospective Cohort 1

Early Liver Transplantation (ELT) for patients who present with Severe Alcoholic Hepatitis (SAH)

liver transplant

Intervention Type PROCEDURE

solid organ transplant

Prospective Cohort 2

Orthotopic Liver Transplantation (OLT) in patient who present with Alcoholic Liver Disease (ALD)

liver transplant

Intervention Type PROCEDURE

solid organ transplant

Interventions

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liver transplant

solid organ transplant

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.


* 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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew M Cameron, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Lee BP, Chen PH, Haugen C, Hernaez R, Gurakar A, Philosophe B, Dagher N, Moore SA, Li Z, Cameron AM. Three-year Results of a Pilot Program in Early Liver Transplantation for Severe Alcoholic Hepatitis. Ann Surg. 2017 Jan;265(1):20-29. doi: 10.1097/SLA.0000000000001831.

Reference Type BACKGROUND
PMID: 27280501 (View on PubMed)

Weeks SR, Sun Z, McCaul ME, Zhu H, Anders RA, Philosophe B, Ottmann SE, Garonzik Wang JM, Gurakar AO, Cameron AM. Liver Transplantation for Severe Alcoholic Hepatitis, Updated Lessons from the World's Largest Series. J Am Coll Surg. 2018 Apr;226(4):549-557. doi: 10.1016/j.jamcollsurg.2017.12.044. Epub 2018 Feb 2.

Reference Type BACKGROUND
PMID: 29409981 (View on PubMed)

Other Identifiers

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P50AA027054

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00154881

Identifier Type: -

Identifier Source: org_study_id