Living Donor Liver Transplantations With Anti-HBc (+) GraftsNCT06290726
Long-term Outcomes of Living Donor Liver Transplantations With Anti-HBc (+) Grafts in Pediatric Patients
An observational study of Living Donor Liver Transplantations With Anti-HBc (+) Grafts, run by Chang Gung Memorial Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 months to 18 years
- Conditions the study is for
- Living Donor Liver Transplantations With Anti-HBc (+) Grafts
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- Feb 2002to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- consecutive pediatric LDLT recipients.
Who cannot join
- Adult LDLT recipients
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Long-term survival in pediatric recipients of living donor liver transplantations with anti-HBc (+) grafts
Investigation of the Long-term survival in pediatric recipients of living donor liver transplantations with anti-HBc (+) grafts
Measured: Feb. 2002-Feb.2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study startFeb 2002
- Primary completionFeb 2016
- Study completionJan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Living Donor Liver Transplantations With Anti-HBc (+) GraftsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chih-Che Lin, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290726
- Sponsor's protocol ID
- 202001927B0
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Active Vaccination Against de Novo Hepatitis B Among Pediatric Recipients of Living Donor Liver Transplantations With Anti-HBc (+) Grafts
- ClinicalTrials.gov ID
- NCT06290726
- Acronym / sponsor ID
- 202001927B0
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Feb 2002 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jan 2024 (actual)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 4 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- consecutive pediatric LDLT recipients.
Key exclusion criteria (1 listed)
- Adult LDLT recipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Living Donor Liver Transplantations With Anti-HBc (+) Grafts, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term survival in pediatric recipients of living donor liver transplantations with anti-HBc (+) grafts (time frame: Feb. 2002-Feb.2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.