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 — PROCEDUREsolid 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 CohortEarly Liver Transplantation (ELT) for patients who presented with Severe Alcoholic Hepatitis (SAH)
- Arm: Prospective Cohort 1Early Liver Transplantation (ELT) for patients who present with Severe Alcoholic Hepatitis (SAH)
- Arm: Prospective Cohort 2Orthotopic 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | - |
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