[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598013":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":84,"collaborators":87,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":26,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":26,"enrollmentInfo":102,"targetDuration":26,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":26,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"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",[45,64,73],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Peking University First Hospital","RECRUITING","Beijing","Beijing Municipality","100034","China","CN",{"type":54,"coordinates":55},"Point",[56,57],116.39723,39.9075,{"lat":57,"lon":56},[60],{"name":61,"role":37,"phone":62,"phoneExt":26,"email":63},"Yu-Jun Dong, MD","+8618210264969","dongy@hsc.pku.edu.cn",{"facility":65,"status":47,"city":48,"state":49,"zip":66,"country":51,"countryCode":52,"cosmosGeoPoint":67,"geoPoint":69,"contacts":70},"Peking University Insititute of Hematology, Peking University People's Hospital","100044",{"type":54,"coordinates":68},[56,57],{"lat":57,"lon":56},[71,72],{"name":32,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},{"facility":74,"status":47,"city":48,"state":49,"zip":75,"country":51,"countryCode":52,"cosmosGeoPoint":76,"geoPoint":78,"contacts":79},"Peking University Third Hospital","100191",{"type":54,"coordinates":77},[56,57],{"lat":57,"lon":56},[80],{"name":81,"role":37,"phone":82,"phoneExt":26,"email":83},"Hong-Mei Jing, MD","+8615611908428","hongmeijing@bjmu.edu.cn",{"type":34,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Xiao Hui Zhang","Vice president of Peking Univeristy Institute of Hematology",[88,90],{"name":89,"class":6},"Peking University Health Science Center",{"name":91,"class":92},"Cisen Pharmaceutical CO., LTD.","INDUSTRY","100598013","phase-2-the-efficacy-and-safety-of-combined-teriflunomide-and-high-dose-dexamethasone-in-newly-diagnosed-primary-immune-thrombocytopenia-tempo-2-100598013",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":103,"type":104},132,"ESTIMATED","INTERVENTIONAL",[107],"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).",[110],"Immune Thrombocytopenia (ITP)","2025-08-31",{"date":113,"type":114},"2025-09-08","ACTUAL",{"date":116,"type":114},"2025-08-19",{"date":118,"type":104},"2027-12-30",{"name":5,"class":6},3]