Immune Thrombocytopenia
Conditions
Keywords
Bruton's Tyrosine Kinase
Brief summary
This project was undertaken to evaluate the efficacy and safety of BTK inhibitor Orelabrutinib 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. Orelabrutinib is administered as 50 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.
Interventions
DRUGOrelabrutinib
50mg po qd 6 weeks
Sponsors
Peking University People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 . |
Countries
China
Contacts
Primary ContactXiao-Hui Zhang, MD
Outcome results
None listed