Liver Diseases Clinical Trial
Official title:
Cohort/Ethics Study of Patients With Severe Alcoholic Hepatitis Undergoing Early Liver Transplantation
Verified date | April 2024 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05255042 -
Tissue Models for Liver Disease
|
||
Completed |
NCT04473482 -
Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial
|
N/A | |
Not yet recruiting |
NCT05120557 -
Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH
|
N/A | |
Completed |
NCT02917408 -
Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
|
||
Recruiting |
NCT03773887 -
Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease
|
N/A | |
Recruiting |
NCT00345930 -
DILIN - Prospective Study
|
||
Completed |
NCT00148031 -
Improving Hepatitis C Treatment in Injection Drug Users
|
Phase 4 | |
Terminated |
NCT00031135 -
Total Parenteral Nutrition-Associated Liver Disease
|
Phase 2 | |
Completed |
NCT00005305 -
Hepatitis Delta Infections in Hemophiliacs
|
N/A | |
Completed |
NCT00005304 -
Delta Hepatitis and Liver Disease in Hemophiliacs
|
||
Completed |
NCT00222664 -
Qidong Hepatitis B Intervention Study
|
Phase 4 | |
Recruiting |
NCT06195917 -
Robotic-assisted Percutaneous Transhepatic Puncture
|
N/A | |
Recruiting |
NCT04551742 -
Social & Contextual Impact on Children Undergoing Liver Transplantation
|
||
Completed |
NCT04782050 -
Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation
|
N/A | |
Completed |
NCT03614039 -
Effect of Probiotic and Smectite Gel on NAFLD
|
N/A | |
Recruiting |
NCT04518852 -
TACE, Sorafenib and PD-1 Monoclonal Antibody in the Treatment of HCC
|
Phase 2 | |
Recruiting |
NCT05499585 -
Treating Pediatric NAFLD With Nutrition
|
N/A | |
Terminated |
NCT03396705 -
Liver Regeneration
|
||
Completed |
NCT04341012 -
Breath Analysis Based Disease Biomarkers of COVID-19 and Other Diseases
|
||
Recruiting |
NCT05733832 -
A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
|
N/A |