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OpenTrials
Completed

NCT Number: NCT06290726

Long-term Outcomes of Living Donor Liver Transplantations With Anti-HBc (+) Grafts in Pediatric Patients

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.

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Key information

Age range

4 month–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • consecutive pediatric LDLT recipients.

Exclusion criteria

  • Adult LDLT recipients

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Long-term Outcomes of Active Vaccination Against de Novo Hepatitis B Among Pediatric Recipients of Living Donor Liver Transplantations With Anti-HBc (+) Grafts

Important dates

Study start
2002
Primary completion
2016
Study completion
2024
First posted
Mar 4, 2024
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.