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HBV Reactivation Prediction Model in Allo-HSCT

NCT07644026 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-06-12

No results posted yet for this study

Summary

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

Conditions

  • HBV Reactivation
  • HSCT

Interventions

OTHER

No Intervention: Observational Cohort

No study-specific intervention will be administered. Participants will receive standard clinical care after allo-HSCTaccording to institutional practice and treating physician discretion. This multicenter study will prospectively collect observational data on HBV reactivation and associated clinical outcomes in HBsAg-negative/anti-HBc-positive patients for at least 36 months post-transplant.

Sponsors & Collaborators

  • Xinqiao Hospital of Chongqing

    collaborator OTHER

  • First Affiliated Hospital of Zhejiang University

    collaborator OTHER

  • Tang-Du Hospital

    collaborator OTHER

  • Institute of Hematology & Blood Diseases Hospital, China

    collaborator OTHER

  • Xiao Hui Zhang

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-20
Primary Completion
2028-07-30
Completion
2029-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07644026 on ClinicalTrials.gov