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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04234139
Other study ID # IRB00154881
Secondary ID P50AA027054
Status Enrolling by invitation
Phase
First received
Last updated
Start date April 1, 2020
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 300
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
liver transplant
solid organ transplant

Locations

Country Name City State
United States Johns Hopkins University Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants who survived within 1 year post-transplant Post-transplant survival within one year of the surgical procedure. 1 years
Secondary Number of participants who self-report or have biochemically measured alcohol recidivism or relapse within 1 year post-transplant Self-reported or biochemically measured alcohol recidivism or relapse. 1 years
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