NCT06787534

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,924

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
8.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

January 14, 2025

Last Update Submit

January 20, 2025

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

  • Postoperative death

    The death of a patient following liver transplanation

    2015.1.1-2023.12.31

Secondary Outcomes (1)

  • Postoperative recurrence

    2015.1.1-2023.12.31

Study Arms (2)

HBcAb negative group

Liver transplant recipients with HBcAb negative grafts

Other: No Interventions

HBcAb positive group

Liver transplant recipients with HBcAb positive grafts

Other: No Interventions

Interventions

No InterventionsOTHER
HBcAb negative groupHBcAb positive group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • (1) primary transplantation; (2) complete baseline data.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 14, 2025

First Posted

January 22, 2025

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

December 31, 2023

Last Updated

January 22, 2025

Record last verified: 2025-01