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

NCT04234139 | Enrolling By Invitation DMC

• 2 other identifiers: IRB00154881P50AA027054
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

liver transplant; alcoholic liver disease

Outcome Measures

Primary Outcomes (1)

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

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

  1 years

Secondary Outcomes (1)

• Number of participants who self-report or have biochemically measured alcohol recidivism or relapse within 1 year post-transplant

  1 years

Study Arms (3)

Retrospective Cohort

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

Procedure: liver transplant

Prospective Cohort 1

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

Procedure: liver transplant

Prospective Cohort 2

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

Procedure: liver transplant

Interventions

liver transplant PROCEDURE

solid organ transplant

Prospective Cohort 1; Prospective Cohort 2; Retrospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Severe Alcoholic Hepatitis patients listed for liver transplatation at Johns Hopkins Hospital and patients undergoing liver transplantation at Johns Hopkins Hospital for Alcoholic Liver Disease

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related 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.

  PMID: 27280501 BACKGROUND

• 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.

  PMID: 29409981 BACKGROUND

MeSH Terms

Conditions

Liver Diseases, Alcoholic; Alcohol-Related Disorders; Rejection, Psychology; Liver Diseases; Hepatitis, Alcoholic; Alcohol-Induced Disorders

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Digestive System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Social Behavior; Behavior; Hepatitis

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Andrew M Cameron, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 21, 2020
• Study Start: April 1, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)