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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
50mg po qd 6 weeks
Peking University Institute of Hematology
Beijing, Beijing Municipality, China
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.
Time frame: 6 weeks
Complete response (CR)
Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding.
Time frame: 6 weeks
Time to response
The time from starting treatment to time of achievement of Response.
Time frame: 6 weeks
Bleeding events
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.
Time frame: 6 weeks
Side effects
Potential side effects include leukopenia, nausea and diarrhea, infectious diseases, etc .
Time frame: 6 weeks
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