Status:
COMPLETED
A Study of Zanubrutinib in Patients With ITP
Lead Sponsor:
Peking University People's Hospital
Conditions:
Immune Thrombocytopenia
Bruton Tyrosine Kinase
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This project was undertaken to evaluate the efficacy and safety of BTK inhibitor Zanubrutinib for the secondary treatment of adults with primary immune thrombocytopenia (ITP).
Detailed Description
The investigators are undertaking a prospective trial of 10 adults with ITP in China. Zanubrutinib is administered as 80 mg po. qd for 6 weeks. Platelet count, bleeding and other symptoms were evaluat...
Eligibility Criteria
Inclusion
- Confirmed primary refractory ITP
- Platelet counts \<30×10\^9/L or with bleeding symptoms
- Willing and able to sign written informed consent
Exclusion
- Secondary thrombocytopenia
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit
- HIV infection or hepatitis B virus or hepatitis C virus infections
- Malignancy
- Severe medical condition (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
- Nursing or pregnant patients
- Patients who are deemed unsuitable for the study by the investigator
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05279872
Start Date
January 1 2022
End Date
October 30 2022
Last Update
October 10 2023
Active Locations (1)
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1
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China, 100010