HBV Reactivation Prediction Model in Allo-HSCT

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorXiao Hui Zhang

About this trial

Hepatitis B virus (HBV) reactivation is a serious complication after allogeneic haematopoietic stem cell transplantation (allo-HSCT), particularly in patients with resolved HBV infection (HBsAg-negative, anti-HBc-positive). The incidence ranges from 10% to 40%, and severe reactivation can lead to hepatitis flare, hepatic failure, and death.

Several risk factors have been identified: low recipient anti-HBs titre, donor anti-HBs negativity, recipient age ≥50 years, chronic GVHD, and use of rituximab. However, no validated clinical prediction model exists for this specific population. The only available study (Zhang et al., BBMT 2020) performed risk factor analysis but did not develop a predictive nomogram, and the sample size was limited (only 16 reactivation events). Therefore, we aim to develop and externally validate a robust nomogram using a large multicentre retrospective cohort and then validate its performance in a prospective cohort

Eligibility criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • No Intervention: Observational Cohort

Treatment groups

300 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Xiao Hui Zhang

Lead sponsor

Peking University People's Hospital

Sponsor institution

Xinqiao Hospital of Chongqing

Collaborator

Zhejiang University

Collaborator

Tang-Du Hospital

Collaborator

Institute of Hematology & Blood Diseases Hospital, China

Collaborator