[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640893":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":31,"locations":41,"responsibleParty":56,"collaborators":60,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":30,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":30,"enrollmentInfo":81,"targetDuration":30,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":93,"whyStopped":30,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ATRA","EXPERIMENTAL","ATRA 10mg twice daily",[13],"Drug: all-trans retinoic acid (ATRA)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo 10mg twice daily",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","all-trans retinoic acid (ATRA)","10mg twice daily ×24 weeks",[9],[27],"tretinoin",{"type":22,"name":15,"description":24,"armGroupLabels":29,"otherNames":30},[15],null,[32,37],{"name":33,"role":34,"phone":35,"phoneExt":30,"email":36},"Xiaohui Zhang, Prof.","CONTACT","861088326001","zhangxh@bjmu.edu.cn",{"name":38,"role":34,"phone":39,"phoneExt":30,"email":40},"Haixia Fu, Dr.","861088326002","fuhaixia_210@163.com",[42],{"facility":43,"status":30,"city":44,"state":30,"zip":30,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Peking University Institute of hematology, People's Hospital","Beijing","China","CN",{"type":48,"coordinates":49},"Point",[50,51],116.39723,39.9075,{"lat":51,"lon":50},[54],{"name":55,"role":34,"phone":35,"phoneExt":30,"email":36},"Xiaohui Zhang",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Xiao Hui Zhang","Vice president of Peking University Institute of Hematology",[61,63,65,67,69],{"name":62,"class":6},"Peking University First Hospital",{"name":64,"class":6},"Beijing Friendship Hospital",{"name":66,"class":6},"Beijing Tongren Hospital",{"name":68,"class":6},"Peking University Third Hospital",{"name":70,"class":71},"Beijing Hospital","OTHER_GOV","100640893","phase-3-atra-for-management-of-primary-itp-100640893",false,"NCT07597395","ATRA for Management of Primary ITP","All-trans Retinoic Acid for Management of Primary Immune Thrombocytopenia : a Randomized, Double-blind, Placebo-controlled Study","Inclusion Criteria:\n\n* Primary ITP if aged ⩾18 years;\n* With an average of two platelet counts ⩾1 day apart of \\\u003C30×10\\^9\u002FL during screening and no single platelet count \\>35×10\\^9\u002FL within 2 weeks before study treatment;\n* Patients who have previously received at least one first-line standard therapy for ITP (corticosteroid and\u002For intravenous immunoglobulin) with unsustained efficacy, relapse, intolerance to standard therapy, or insufficient response.\n\nExclusion Criteria:\n\n* Pregnant or lactating women, and who were possibly pregnant, planning to become pregnant, or who had partners planning to become pregnant;\n* With active malignancy or a history of malignant tumor;\n* Having experienced severe bacterial, viral, fungal or parasitic infection within the past 4 weeks;\n* With a history of symptomatic herpes zoster infection within 12 weeks prior to screening;\n* Active or chronic HBV, HCV or HIV infection;\n* Evidence of active tuberculosis; or previous evidence of active tuberculosis without appropriate and documented treatment; or household contact with patients with active tuberculosis without appropriate and documented tuberculosis prophylaxis;\n* Receipt of live vaccines within the past 12 weeks, or planned live vaccination during the study period;\n* Prior ATRA therapy;\n* History of solid organ transplant or planned surgery;\n* Myelodysplastic syndrome, aplastic anemia or myelofibrosis;\n* Patients with other diseases were undergoing treatment with immunosuppressants;\n* Clinically significant thromboembolic events within the past 24 weeks, or ongoing anticoagulant treatment, who are deemed ineligible for the study by the investigator;\n* History or presence of myocardial infarction, unstable ischemic heart disease, stroke, or NYHA Class IV heart failure;\n* History or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, neurological, neuropsychiatric or any other severe and\u002For unstable diseases that, in the opinion of the investigator, may pose an unacceptable risk with the investigational product or interfere with the interpretation of study data;\n* AST \\> 2 times the upper limit of normal (ULN), ALT \\> 2×ULN, TBIL ≥ 1.5×ULN;\n* WBC \\\u003C 2500\u002FµL, neutrophil count \\\u003C 1200\u002FµL, lymphocyte count \\\u003C 750\u002FµL, hemoglobin \\\u003C 9 g\u002FdL;\n* eGFR \\\u003C 50 mL\u002Fmin\u002F1.73m²;\n* Other patients deemed unsuitable for enrollment in this study by the investigator.","ALL","18 Years",{"count":82,"type":83},192,"ESTIMATED","INTERVENTIONAL",[86],"PHASE3","A multicenter, randomized, double-blind placebo-controlled study to report the efficacy and safety of all-trans etinoic acid compared to placebo for the treatment of adults with corticosteriod-resistant\u002Frelapsed primary immune thrombocytopenia (ITP).",[89],"Immune Thrombocytopenia",[91,92,9],"Immune thrombocytopenia;","Corticosteriod resistance resistant\u002Frelaped","NOT_YET_RECRUITING","2026-05-13",{"date":96,"type":97},"2026-05-19","ACTUAL",{"date":99,"type":83},"2026-05-30",{"date":101,"type":83},"2028-12-30",{"name":5,"class":6},1]