[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617188":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":44,"centralContacts":49,"locations":31,"responsibleParty":58,"collaborators":31,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":31,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":31,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":83,"whyStopped":31,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":31},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Zanubrutinib 80mg\u002Fd + Dexamethasone","EXPERIMENTAL","Participants in this arm will receive a combination therapy consisting of:\n\nZanubrutinib: 80 mg taken orally once daily for 26 weeks. Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved.",[13,14],"Drug: Zanubrutinib 80mg\u002Fd","Drug: High dose dexamethasone",{"label":16,"type":10,"description":17,"interventionNames":18},"Zanubrutinib 160mg\u002Fd + Dexamethasone","Participants in this arm will receive a combination therapy consisting of:\n\nZanubrutinib: 160 mg taken orally once daily for 26 weeks. Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved.",[14,19],"Drug: Zanubrutinib 160mg\u002Fd",{"label":21,"type":10,"description":22,"interventionNames":23},"Zanubrutinib 240mg\u002Fd + Dexamethasone","Participants in this arm will receive a combination therapy consisting of:\n\nZanubrutinib: 240 mg taken orally once daily for 26 weeks. Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved.",[14,24],"Drug: Zanubrutinib 240mg\u002Fd",[26,32,36,40],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Zanubrutinib 80mg\u002Fd","Zanubrutinib: 80 mg taken orally once daily for 26 weeks",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"High dose dexamethasone","Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved.",[16,21,9],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Zanubrutinib 160mg\u002Fd","Zanubrutinib: 160 mg taken orally once daily for 26 weeks",[16],{"type":27,"name":41,"description":42,"armGroupLabels":43,"otherNames":31},"Zanubrutinib 240mg\u002Fd","Zanubrutinib: 240 mg taken orally once daily for 26 weeks",[21],[45],{"name":46,"affiliation":47,"role":48},"Xiaohui Zhang","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","PRINCIPAL_INVESTIGATOR",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":31,"email":54},"Xiaohui Zhang, MD","CONTACT","8688324577","zhangxh100@sina.com",{"name":56,"role":52,"phone":53,"phoneExt":31,"email":57},"Qiusha Huang, MD","huangfuqs@163.com",{"type":48,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Xiao Hui Zhang","Vice president of Peking University Institute of Hematology","100617188","phase-1-optimal-dose-of-zanubrutinib-to-treat-adult-immune-thrombocytopenia-100617188",false,"NCT07315373","Optimal Dose of Zanubrutinib to Treat Adult Immune Thrombocytopenia","The FIND Study: A Dose-finding Study to Identify the Optimal Dose of Zanubrutinib in Adults With Immune Thrombocytopenia","Inclusion Criteria:\n\n1. Confirmed newly-diagnosed, treatment-naive ITP;\n2. Platelet counts \\\u003C30×10\\^9\u002FL ;\n3. Platelet counts \\\u003C 50×10\\^9\u002FL and significant bleeding symptoms (WHO bleeding scale 2 or above);\n4. Willing and able to sign written informed consent.\n\nExclusion Criteria:\n\n1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;\n2. Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;\n3. Current HIV infection or hepatitis B virus or hepatitis C virus infections;\n4. Active infection;\n5. Maligancy;\n6. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia);\n7. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy\n8. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;\n9. Patients who are deemed unsuitable for the study by the investigator.","ALL","18 Years","70 Years",{"count":72,"type":73},60,"ESTIMATED","INTERVENTIONAL",[76],"PHASE1","The goal of this clinical trial is to find the best dose of zanubrutinib when used together with high-dose dexamethasone for adults who are newly diagnosed with primary immune thrombocytopenia (ITP), and to learn how safe and effective this combination treatment is.",[79],"Immune Thrombocytopenia",[81,82],"ITP","zanubrutinib","NOT_YET_RECRUITING","2025-12-18",{"date":86,"type":87},"2026-01-02","ACTUAL",{"date":89,"type":73},"2025-12-25",{"date":91,"type":73},"2029-06-30",{"name":5,"class":6}]