Liver TransplantationNCT06787534
The Favorable Impact of HBcAb Positive Grafts on Liver Transplantation for HBV-related HCC
An observational study of Liver Transplantation, run by Xiao Xu.
Trial summary
The utilization of marginal grafts may help alleviate the demand mismatch. However, strategies to optimize the use of hepatitis B core antibody (HBcAb) positive grafts still requires further investigation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- How many people
- 6,924 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2023
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Of the patients, 18.4% were female, and the median age of the patients was 50 years (range 18-82 years; IQR 43-56 years). The median value of the laboratory MELD score was 25 (IQR 13-35). The median follow-up duration for the study cohort was 44.7 months (IQR 16.0-65.3 months).
Who may be able to join
- (1) primary transplantation; (2) complete baseline data.
Who cannot join
- (1) re-transplantation, combined organ transplantation or living donor liver transplantation; (2) intrahepatic cholangiocarcinoma or combined hepatocellular-cholangiocarcinoma; (3) HBsAg positive graft; and (4) missing of baseline data. Patients who were lost to follow-up were also excluded.
About this study
Official title: The Favorable Impact of Hepatitis B Core Antibody Positive Grafts on Liver Transplantation for Hepatitis B Virus-related Hepatocellular Carcinoma: a Nationwide Multicenter Retrospective Cohort Study
The utilization of marginal grafts may help alleviate the demand mismatch. However, strategies to optimize the use of hepatitis B core antibody (HBcAb) positive grafts still requires further investigation. This study aims to investigate possible interactions between HBcAb positive grafts, HCC and HBV-related diseases, and long-term patient and graft survival. The study retrospectively analyzed patients undergoing liver transplantation in 8 centers between January 2015 and December 2020.
Read the detailed description
This retrospective observational study included patients who underwent liver transplantation between January 2015 and December 2020 from 8 transplant centers in China, including the First Affiliated Hospital, Zhejiang University School of Medicine, Shulan (Hangzhou) Hospital, the Affiliated Hospital of Qingdao University, the Third Affiliated Hospital of Sun Yat-sen University, West China Hospital of Sichuan University, HuaShan Hospital of Fudan University, Beijing Chaoyang Hospital of Capital Medical University, and the Second Xiangya Hospital of Central South University. Demographic and clinicopathological data of these patients were extracted from the prospectively maintained China Liver Transplant Registry (CLTR) database. The exclusion criteria were as follows: (1) re-transplantation, combined organ transplantation or living donor liver transplantation; (2) intrahepatic cholangiocarcinoma or combined hepatocellular-cholangiocarcinoma; (3) HBsAg positive graft; and (4) missing of baseline data. Patients who were lost to follow-up were also excluded.
Statistical analysis was performed with GraphPad Prism (Version 9), IBM SPSS Statistics (Version 26) and R version 4.3.1 (R Foundation). Regarding the initial demographic data, continuous variables were depicted as medians (IQR: Inter-Quartile Range) and analyzed for differences with the Mann-Whitney U test. Categorical variables were contrasted through the application of the chi-squared test. Cumulative patient survival, graft survival, recurrence-free survival and recurrence rate were analyzed by the Kaplan-Meier method and compared with the log-rank test. To lessen the impact of potential confounders and selection bias, propensity score matching (PSM) was implemented to form comparable groups. Unbalanced variables were entered into the 1:1 matching model. Cox proportional hazard models were used to estimate hazard ratios (HRs) with 95% confidence intervals (CIs) for the relationship between variables and the event of interest. Univariate analyses were performed to identify the potential risk factors for patient survival, graft survival and recurrence-free survival in each group. Variables (P<0.10) were included in the backward stepwise multivariate analyses.
- Conditions
- Liver Transplantation
- Being tested
- No Interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
| Study group | Role | What they receive |
|---|---|---|
| HBcAb negative group | Liver transplant recipients with HBcAb negative grafts Receives: Other: No Interventions | |
| HBcAb positive group | Liver transplant recipients with HBcAb positive grafts Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative death
The death of a patient following liver transplanation
Measured: 2015.1.1-2023.12.31
Secondary outcomes (1)
Postoperative recurrence
The day of hepatocellular carcinoma recurrence
Measured: 2015.1.1-2023.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Jan 2015
- Primary completion1 Jun 2015
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- 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
- 6,924 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiao Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiao Xu, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787534
- Sponsor's protocol ID
- CT-2025-ZJU-OBS01
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Favorable Impact of Hepatitis B Core Antibody Positive Grafts on Liver Transplantation for Hepatitis B Virus-related Hepatocellular Carcinoma: a Nationwide Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06787534
- Acronym / sponsor ID
- CT-2025-ZJU-OBS01
- Conditions
- Liver Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,924 participants (actual)
- Lead sponsor
- Xiao XuUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jun 2015 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Jan 2025 (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 utilization of marginal grafts may help alleviate the demand mismatch. However, strategies to optimize the use of hepatitis B core antibody (HBcAb) positive grafts still requires further investigation. This study aims to investigate possible interactions between HBcAb positive grafts, HCC and HBV-related diseases, and long-term patient and graft survival. The study retrospectively analyzed patients undergoing liver transplantation in 8 centers between January 2015 and December 2020.
Detailed description
This retrospective observational study included patients who underwent liver transplantation between January 2015 and December 2020 from 8 transplant centers in China, including the First Affiliated Hospital, Zhejiang University School of Medicine, Shulan (Hangzhou) Hospital, the Affiliated Hospital of Qingdao University, the Third Affiliated Hospital of Sun Yat-sen University, West China Hospital of Sichuan University, HuaShan Hospital of Fudan University, Beijing Chaoyang Hospital of Capital Medical University, and the Second Xiangya Hospital of Central South University. Demographic and clinicopathological data of these patients were extracted from the prospectively maintained China Liver Transplant Registry (CLTR) database. The exclusion criteria were as follows: (1) re-transplantation, combined organ transplantation or living donor liver transplantation; (2) intrahepatic cholangiocarcinoma or combined hepatocellular-cholangiocarcinoma; (3) HBsAg positive graft; and (4) missing of baseline data. Patients who were lost to follow-up were also excluded.
Statistical analysis was performed with GraphPad Prism (Version 9), IBM SPSS Statistics (Version 26) and R version 4.3.1 (R Foundation). Regarding the initial demographic data, continuous variables were depicted as medians (IQR: Inter-Quartile Range) and analyzed for differences with the Mann-Whitney U test. Categorical variables were contrasted through the application of the chi-squared test. Cumulative patient survival, graft survival, recurrence-free survival and recurrence rate were analyzed by the Kaplan-Meier method and compared with the log-rank test. To lessen the impact of potential confounders and selection bias, propensity score matching (PSM) was implemented to form comparable groups. Unbalanced variables were entered into the 1:1 matching model. Cox proportional hazard models were used to estimate hazard ratios (HRs) with 95% confidence intervals (CIs) for the relationship between variables and the event of interest. Univariate analyses were performed to identify the potential risk factors for patient survival, graft survival and recurrence-free survival in each group. Variables (P<0.10) were included in the backward stepwise multivariate analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBcAb negative group | – | Other: No InterventionsLiver transplant recipients with HBcAb negative grafts |
| HBcAb positive group | – | Other: No InterventionsLiver transplant recipients with HBcAb positive grafts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Of the patients, 18.4% were female, and the median age of the patients was 50 years (range 18-82 years; IQR 43-56 years). The median value of the laboratory MELD score was 25 (IQR 13-35). The median follow-up duration for the study cohort was 44.7 months (IQR 16.0-65.3 months).
Key inclusion criteria (1 listed)
- (1) primary transplantation; (2) complete baseline data.
Key exclusion criteria (1 listed)
- (1) re-transplantation, combined organ transplantation or living donor liver transplantation; (2) intrahepatic cholangiocarcinoma or combined hepatocellular-cholangiocarcinoma; (3) HBsAg positive graft; and (4) missing of baseline data. Patients who were lost to follow-up were also excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Interventions | Other | HBcAb negative group, HBcAb positive group |
Primary outcome
Postoperative death
Time frame: 2015.1.1-2023.12.31
The death of a patient following liver transplanation
1 secondary outcome
Postoperative recurrence
Time frame: 2015.1.1-2023.12.31
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 22 Jan 2025.
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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 Liver Transplantation, run by Xiao Xu.
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 22 Jan 2025. 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?
Postoperative death (time frame: 2015.1.1-2023.12.31). 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 22 Jan 2025.