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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower Dose | Experimental | Orelabrutinib is a white, round, uncoated tablet |
|
| Higher Dose | Experimental | Orelabrutinib is a white, round, uncoated tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orelabrutinib( lower dose) | Drug | Orelabrutinib is a white, round, uncoated tablet, will be taken lower dose QD by patients with persistent or chronic primary immune thrombocytopenia |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with the platelet count of ≥ 50 × 109/L after 12 weeks of treatment | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 25 weeks | |
| Occurrence of treatment emergent adverse events (TEAE) and treatment-related adverse events (TRAE) were evaluated according to severity |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | To obtain pharmacokinetic (PK) data of Orelabrutinib include the peak plasma concentration (Cmax) | 25 weeks |
Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Hou, PhD | Contact | 18560087007 | houming@medmail.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hainan People's Hospital | Recruiting | Haikou | Hainan | 570100 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38546375 | Derived | Yan S, Zhou H, Huang R, Wang F, Mei H, Lin L, Guo J, Zhou X, Li Z, Liu Y, Li S, Zhou W, Hou Y, Hou M. A phase 2 trial of orelabrutinib showing promising efficacy and safety in patients with persistent or chronic primary immune thrombocytopenia. Am J Hematol. 2024 Jul;99(7):1392-1395. doi: 10.1002/ajh.27303. Epub 2024 Mar 28. No abstract available. |
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| Orelabrutinib( higher dose) | Drug | Orelabrutinib is a white, round, uncoated tablet, will be taken higher dose QD by patients with persistent or chronic primary immune thrombocytopenia |
|
| 25 weeks |
| Henan Tumor Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
|
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450000 | China |
|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430000 | China |
|
| Yichang Central People's Hospital | Recruiting | Yichang | Hubei | 443000 | China |
|
| Wuxi People's Hospital | Recruiting | Wuxi | Jiangsu | 214000 | China |
|
| Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | 221000 | China |
|
| First Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330000 | China |
|
| QiLu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
|
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
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| ID | Term |
|---|---|
| C000729508 | orelabrutinib |
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