A Study of Zanubrutinib in Patients With ITP
1 other identifier
interventional
20
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2022
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
January 24, 2022
CompletedFirst Posted
Study publicly available on registry
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2022
CompletedOctober 10, 2023
October 1, 2023
10 months
January 24, 2022
October 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Overall response (OR)
The maintenance of platelet count ≥ 30 x 10\^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 6-week follow-up.
6 weeks
Secondary Outcomes (4)
Complete response (CR)
6 weeks
Time to response
6 weeks
Bleeding events
6 weeks
Side Effects
6 weeks
Study Arms (1)
Zanubrutinib
EXPERIMENTALZanubrutinib 80mg po qd 6 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed primary refractory ITP
- Platelet counts \<30×10\^9/L or with bleeding symptoms
- Willing and able to sign written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, 100010, China
Related Publications (1)
Huang QS, Fu HX, Wang CC, Zhu XL, He Y, Wu J, Chen Q, Zhao P, An ZY, Liu KY, Huang XJ, Zhang XH. Efficacy and Safety of the Bruton's Tyrosine Kinase Inhibitor Zanubrutinib in Immune Thrombocytopenia. Am J Hematol. 2025 Aug;100(8):1314-1322. doi: 10.1002/ajh.27718. Epub 2025 May 20.
PMID: 40391880DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiao-Hui Zhang, MD
Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice president of Peking University Institute of Hematology
Study Record Dates
First Submitted
January 24, 2022
First Posted
March 15, 2022
Study Start
January 1, 2022
Primary Completion
October 30, 2022
Study Completion
October 30, 2022
Last Updated
October 10, 2023
Record last verified: 2023-10