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Prophylaxis of HBV reactivation by vaccination enforcing post-transplant HBV immunity

Prophylaxis of HBV reactivation by vaccination enforcing post-transplant HBV immunity - PREVENT HBV

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034113
Enrollment
150
Registered
2018-09-24
Start date
2018-09-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HSCT recipient with resolved infection of HBV

Interventions

HB vaccine arm HBV DNA and anti-HBs antibody are monitored every 28 days, and preemptive nucleoside analogue is administered when reactivation of HBV is observed. Inoculations of HB vaccine are pla

Sponsors

National Center for Global Health and Medicine Genome Medical Science Project
Lead Sponsor
The Japanese Data Center for Hematolopoietic Cell Transplantation SRL
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patient is planed to undergo 1st hematopoietic stem cell transplantation (2) HBs antigen negative and anti-HBc antibody positive (3) more than 20 year-old and less than 70 year-old (4) Those patient who give written informed consent

Exclusion criteria

Exclusion criteria: (1) anti-HCV antibody negative (2) anti-HIV antibody negative (3) HBV DNA>=1.3 Log IU/mL (4) anti-HBc antibody negative (5) seroconversion of anti-HBc antibody negative to positive after infusion of blood product (6) previous HBV reactivation (7) previous history of treatment using nucleoside analogue, or plan to prescribe nucleoside analogue for prophylaxis (8) anaphylaxis for previous vaccine (9) conditioning regimen has been started for first HSCT (10) complication of severe infection (11) hemodialysis has been started or planed to be induced (12) uncontrollable diabetics, hypertension or heart failure (13) woman during pregnant or lactation (14) patient who plan to move or plan to be followed by other institute during 2-year after HSCT (15) patient who is not been considered to be eligible to the study by a doctor in charge by miscellaneous reasons

Design outcomes

Primary

MeasureTime frame
HBV reactivation

Countries

Japan

Contacts

Public ContactMasahiro Onozawa

Hokkaido University Hospital Department of Hematology

onozawa@med.hokudai.ac.jp011-706-7214

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026