[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598013":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":83,"collaborators":86,"id":92,"slug":26,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":26,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":26,"enrollmentInfo":100,"targetDuration":26,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":26,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Teriflunomide plus Dexamethasone","EXPERIMENTAL","Oral Teriflunomide was given at a dose of 14 mg once daily for 24 weeks, and dexamethasone was given at a dose of 40mg orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Nonresponsive participants with platelets less than 30 x10\\^9\u002FL or with active bleeding were allowed to repeat the 4-day course of dexamethasone treatment.",[13,14],"Drug: Teriflunomide","Drug: Dexamethasone",{"label":16,"type":17,"description":18,"interventionNames":19},"Dexamethasone","ACTIVE_COMPARATOR","Dexamethasone was given at a dose of 40mg, orally once per day for 4 consecutive days (Days 1, 2, 3, and 4). Nonresponsive participants with platelets less than 30 x10\\^9\u002FL or with active bleeding were allowed to repeat the 4-day course of dexamethasone treatment.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Teriflunomide","Teriflunomide 14 mg orally once daily for 24 weeks.",[9],null,{"type":22,"name":16,"description":28,"armGroupLabels":29,"otherNames":26},"Dexamethasone 40 mg orally once daily for four consecutive days.",[16,9],[31],{"name":32,"affiliation":33,"role":34},"Xiao-Hui Zhang, MD","Peking University Institute of Hematology, Peking University People's Hospital","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+8613522338836","zhangxh@bjmu.edu.cn",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Li-Ping Yang, MD","+8618519172033","lpyang@bjmu.edu.cn",[45,63,72],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Peking University First Hospital","RECRUITING","Beijing","Beijing Municipality","100034","China",{"type":53,"coordinates":54},"Point",[55,56],116.39723,39.9075,{"lat":56,"lon":55},[59],{"name":60,"role":37,"phone":61,"phoneExt":26,"email":62},"Yu-Jun Dong, MD","+8618210264969","dongy@hsc.pku.edu.cn",{"facility":64,"status":47,"city":48,"state":49,"zip":65,"country":51,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"Peking University Insititute of Hematology, Peking University People's Hospital","100044",{"type":53,"coordinates":67},[55,56],{"lat":56,"lon":55},[70,71],{"name":32,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},{"facility":73,"status":47,"city":48,"state":49,"zip":74,"country":51,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},"Peking University Third Hospital","100191",{"type":53,"coordinates":76},[55,56],{"lat":56,"lon":55},[79],{"name":80,"role":37,"phone":81,"phoneExt":26,"email":82},"Hong-Mei Jing, MD","+8615611908428","hongmeijing@bjmu.edu.cn",{"type":34,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Xiao Hui Zhang","Vice president of Peking Univeristy Institute of Hematology",[87,89],{"name":88,"class":6},"Peking University Health Science Center",{"name":90,"class":91},"Cisen Pharmaceutical CO., LTD.","INDUSTRY","100598013",false,"NCT07065968","The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)","Teriflunomide and High-dose Dexamethasone vs High-dose Dexamethasone Alone as First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Prospective, Multicenter, Randomized Trial","Inclusion Criteria:\n\n1. Patients aged ≥18 years;\n2. Newly diagnosed, treatment naïve ITP patients;\n3. Patients with a platelet count \\\u003C30 x10\\^9\u002FL or a platelet count \\\u003C50 x10\\^9\u002FL with bleeding manifestations at the enrollment;\n4. Willing and able to sign written informed consent.\n\nExclusion Criteria:\n\n1. Secondary ITP such as drug-related thrombocytopenia, viral infection (HIV, hepatitis B virus, or hepatitis C virus);\n2. Pre-existing acute or chronic liver disease, or ALT\u002FAST greater than 2 times the upper limit of normal (ULN);\n3. Severe cardiac, renal, hepatic, or respiratory insufficiency;\n4. Severe immunodeficiency;\n5. Pregnancy or lactation;\n6. Active or a history of malignancy;\n7. Active infection requiring systemic therapy;\n8. Myelodysplastic syndrome, aplastic anemia, or myelofibrosis;\n9. A known diagnosis of other autoimmune diseases;\n10. Patients who are deemed unsuitable for the study by the investigator.","ALL","18 Years",{"count":101,"type":102},132,"ESTIMATED","INTERVENTIONAL",[105],"PHASE2","A multicenter, open-label, randomized study to report the efficacy and safety of teriflunomide plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with newly diagnosed primary immune thrombocytopenia (ITP).",[108],"Immune Thrombocytopenia (ITP)","2025-08-31",{"date":111,"type":112},"2025-09-08","ACTUAL",{"date":114,"type":112},"2025-08-19",{"date":116,"type":102},"2027-12-30",{"name":5,"class":6},3]