A Study of Zanubrutinib in Patients With ITP
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
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 evaluated before and after treatment. Adverse events are also recorded throughout the study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Zanubrutinib Zanubrutinib 80mg po qd 6 weeks |
Drug: Zanubrutinib
Zanubrutinib 80mg po qd 6 weeks
|
Outcome Measures
Primary Outcome Measures
- Overall response (OR) [6 weeks]
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.
Secondary Outcome Measures
- Complete response (CR) [6 weeks]
Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding.
- Time to response [6 weeks]
The time from starting treatment to time of achievement of Response.
- Bleeding events [6 weeks]
The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss.
- Side Effects [6 weeks]
Potential side effects include leukopenia, nausea and diarrhea, infectious diseases, etc .
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Confirmed primary refractory ITP
-
Platelet counts <30×10^9/L or with bleeding symptoms
-
Willing and able to sign written informed consent
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University Insititute of Hematology, Peking University People's Hospital | Beijing | Beijing | China | 100010 |
Sponsors and Collaborators
- Peking University People's Hospital
Investigators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- PKU-ITP032