Long-term Outcomes of Living Donor Liver Transplantations With Anti-HBc (+) Grafts in Pediatric Patients
March 3, 2024 updated by: Chih-Che Lin, Chang Gung Memorial Hospital
Long-term Outcomes of Active Vaccination Against de Novo Hepatitis B Among Pediatric Recipients of Living Donor Liver Transplantations With Anti-HBc (+) Grafts
The goal of this observational study is to compare in anti-HBc (+) grafts/ anti-HBc (-) grafts.
The main question it aims to answer is the long-term efficacy of active vaccination and graft/patient outcomes of anti-HBc (+) grafts have yet to be comprehensively investigated.
Researchers will compare anti-HBc (+) grafts/ anti-HBc (-) to see if it would affect the long-term survival.
Study Overview
Status
Completed
Detailed Description
A particular strength of the present study is in the inclusion of a consecutive cohort of pediatric LDLT recipients with long-term details of follow-up, although there are several limitations.
First, this was a retrospective study conducted at a single medical center.
Second, the HBV prophylaxis changed from lamivudine to entecavir in 2008, therefore investigators were unable to evaluate the risk of developing lamivudine resistance.
In addition, the DNA level data for the donor and graft tissues were lacking.
Lastly, this study was conducted in an area with a high prevalence of anti-HBc positivity.
Study Type
Observational
Enrollment (Actual)
204
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
The consecutive pediatric LDLT recipients enrolled at a tertiary medical center from February 2002 to February 2016, with follow-up to December 2023.
Description
Inclusion Criteria:
- consecutive pediatric LDLT recipients.
Exclusion Criteria:
- Adult LDLT recipients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
living donor liver transplantations with anti-HBc (+) grafts
No intervention(s) had been administered.
|
|
living donor liver transplantations with anti-HBc (-) grafts
No intervention(s) had been administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Long-term survival in pediatric recipients of living donor liver transplantations with anti-HBc (+) grafts
Time Frame: Feb. 2002-Feb.2016
|
Investigation of the Long-term survival in pediatric recipients of living donor liver transplantations with anti-HBc (+) grafts
|
Feb. 2002-Feb.2016
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2002
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
January 1, 2024
Study Registration Dates
First Submitted
February 26, 2024
First Submitted That Met QC Criteria
February 26, 2024
First Posted (Actual)
March 4, 2024
Study Record Updates
Last Update Posted (Estimated)
March 5, 2024
Last Update Submitted That Met QC Criteria
March 3, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 202001927B0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.