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A prospective, multiple center trial for incidence and prevention of hepatitis B virus (HBV) reactivation following hematopoietic stem cell transplantation (HSCT)

A prospective, multiple center trial for incidence and prevention of hepatitis B virus (HBV) reactivation following hematopoietic stem cell transplantation (HSCT) - A trial for HBV reactivation in HSCT recipients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011543
Enrollment
66
Registered
2013-08-23
Start date
2013-09-01
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

Patients with resolved HBV infection who receive hematopoietic stem cell transplantation

Interventions

HB vaccination

Sponsors

Kiminori Kimura
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who will undergo first HSCT 2. Patients with HBs antigen negative and HBc antibody positive 3. Patients with serum total bilirubin <=2.0mg/dl 4. Patients with serum AST and ALT <= 2.5 x ULN 5. Patients with serum creatinine <= 1.5 xULN 6. Patients with PaO2 >=60Torr on room air or SpO2 >=90% 7.Patients with performance status 0,1 or 2 8. Patients who are 20 to 75 years old 9. Patients who gave consent for this trial

Exclusion criteria

Exclusion criteria: 1. Patients with HCV antibody positive 2. Patients with HIV antibody positive 3. Patients who are allergic to vaccination 4. Patients who are allergic to biologics 5. Patients with severe infectious disease (Patients whose general condition seemed to be poor like as septic shock ) 6. Patient who undergo hemodialysis 7. Patients with mental disorder which is object of treatment 8. Patients with poorly controlled DM, HT, or heart failure 9. Patients who are pregnant or nursing 10. Patients who are judged ineligible for this trial

Design outcomes

Primary

MeasureTime frame
Frequency of HBV reactivation in HSCT recipients immunized with HB vaccination.

Countries

Japan

Contacts

Public ContactKiminori Kimura

Tokyo Metropolitan Komagome Hospital Division of Hepatology

kiminori_kimura@tmhp.jp03-3823-2101

Outcome results

None listed

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