The study is designed to be a randomized, open, multi-center, phase IIa/IIb seamless adaptive trial. Phase IIa: The study consists of a screening period, a core treatment period, an open label extension period, and a safety follow-up period Phase IIb: At present, a preliminary exploratory study (i.e., phase IIa study) will be conducted first. The design of the phase IIb study (including the selection of populations) will be clarified after a relatively clear understanding of the therapeutic effect, value, risks and benefits of the BTK inhibitor for ITP is obtained.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Orelabrutinib is a white, round, uncoated tablet, will be taken lower dose QD by patients with persistent or chronic primary immune thrombocytopenia
Orelabrutinib is a white, round, uncoated tablet, will be taken higher dose QD by patients with persistent or chronic primary immune thrombocytopenia
Hainan People's Hospital
Haikou, Hainan, China
RECRUITINGHenan Tumor Hospital
Zhengzhou, Henan, China
RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGYichang Central People's Hospital
Yichang, Hubei, China
RECRUITINGWuxi People's Hospital
Wuxi, Jiangsu, China
RECRUITINGAffiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGFirst Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITINGQiLu Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGProportion of subjects with the platelet count of ≥ 50 × 109/L after 12 weeks of treatment
Time frame: 12 weeks
Proportion of subjects who achieve a complete response (CR) over treatment time. CR is defined as a post-treatment platelet count of ≥100 × 109/L
Time frame: 25 weeks
Occurrence of treatment emergent adverse events (TEAE) and treatment-related adverse events (TRAE) were evaluated according to severity
Time frame: 25 weeks
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