[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597930":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":55,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":26,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":26,"overallStatus":86,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Upadacitinib and HD-DXM","EXPERIMENTAL","Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone was repeated in the case of lack of response by day 10) and Upadacitinib 15mg qd po, 12 consecutive weeks",[13,14],"Drug: Dexamethasone","Drug: Upadacitinib",{"label":16,"type":17,"description":18,"interventionNames":19},"HD-DXM","ACTIVE_COMPARATOR","Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone was repeated in the case of lack of response by day 10)",[13],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dexamethasone","Dexamethasone, 40 mg\u002Fd, for 4 days (The 4-day course of dexamethasone was repeated in the case of lack of response by day 10)",[16,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Upadacitinib","Upadacitinib 15mg qd for 12 weeks",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Xiaohui Zhang","CONTACT","+8613522338836","zhangxh100@sina.com",[38],{"facility":5,"status":26,"city":39,"state":26,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Beijing","100044","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50],{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Xiao Hui Zhang","Vice president of Peking Univeristy Institute of Hematology",[56,59,61,63,65],{"name":57,"class":58},"Beijing Hospital","OTHER_GOV",{"name":60,"class":6},"Navy General Hospital, Beijing",{"name":62,"class":6},"Beijing Aerospace General Hospital",{"name":64,"class":6},"Qilu Hospital of Shandong University",{"name":66,"class":6},"Beijing Tongren Hospital","100597930","phase-2-the-combination-of-upadacitinib-and-high-dose-dexamethasone-as-first-line-treatment-in-adult-immune-thrombocytopenia-100597930",false,"NCT07064889","The Combination of Upadacitinib and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia","The Combination of Oral Upadacitinib and High-dose Dexamethasone vs High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia: A Multicenter, Randomized, Open-label Trial","Inclusion Criteria:\n\n1. Confirmed newly-diagnosed, treatment-naive ITP;\n2. Platelet counts \\\u003C30×109\u002FL ;\n3. Platelet counts \\\u003C 50×109\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 chronic 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":78,"type":79},132,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","Randomized, open-label, multicenter study to compare the efficacy and safety of Upadacitinib plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (ITP).",[85],"Immune Thrombocytopenia","NOT_YET_RECRUITING","2025-07-07",{"date":89,"type":90},"2025-07-15","ACTUAL",{"date":92,"type":79},"2025-07-30",{"date":94,"type":79},"2027-12-30",{"name":5,"class":6},1]