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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT04234139
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • liver transplant — PROCEDURE
    solid organ transplant

Study Details

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.

Key Dates

Start date
Apr 1, 2020
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Retrospective Cohort
    Early Liver Transplantation (ELT) for patients who presented with Severe Alcoholic Hepatitis (SAH)
  • Arm: Prospective Cohort 1
    Early Liver Transplantation (ELT) for patients who present with Severe Alcoholic Hepatitis (SAH)
  • Arm: Prospective Cohort 2
    Orthotopic Liver Transplantation (OLT) in patient who present with Alcoholic Liver Disease (ALD)

Primary Outcome Measure

Number of participants who survived within 1 year post-transplant [ Time Frame: 1 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21205-

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