Status:
NOT_YET_RECRUITING
Optimal Timing of Hepatitis B Vaccination After Transplants
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Transplant-Related Disorder
Hepatitis B Virus Infection
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The investigators aim to perform a randomized clinical trial to determine the optimal timing of hepatitis B vaccination after hematopoietic cell transplantation (HCT) through evaluating the immunity e...
Eligibility Criteria
Inclusion
- Patients must be ≥ 16 years old;
- Patients receiving hematopoietic cell transplantation;
- Patients achieving complete molecular remission;
- Patients or their guardians have to sign an informed consent form before the start of the research procedure.
Exclusion
- Multiple transplantations;
- Donors' HBV-DNA or HBsAg are positive;
- Patients' HBV-DNA or HBsAg are positive before transplantation or \< 3 months after transplantation;
- Patients who are unable to comply with the research treatments and monitoring requirements due to mental or other medical conditions;
- Patients who are ineligible for the study due to other reasons which would cause unacceptable risks to the patients.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT06888479
Start Date
June 1 2025
End Date
March 1 2029
Last Update
March 21 2025
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020