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

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04234139
• Other study ID #: IRB00154881
• Secondary ID: P50AA027054
• Status: Enrolling by invitation
• 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
• 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.

Related Conditions & MeSH terms

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

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