[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571617":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":34,"locations":40,"responsibleParty":177,"collaborators":181,"id":185,"slug":33,"hasResults":186,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":186,"sex":192,"minAge":193,"maxAge":33,"enrollmentInfo":194,"targetDuration":33,"studyType":197,"phases":198,"briefSummary":200,"conditions":201,"keywords":204,"overallStatus":43,"whyStopped":33,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":218},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Participants receive sirolimus 1 mg (two pills) once daily for 6 months during the randomized, double-blind phase. Participants who do not achieve the primary endpoint at Month 6 may enter a 3-month open-label extension and receive sirolimus 1.5 mg once daily.",[13],"Drug: Sirolimus",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","PLACEBO_COMPARATOR","Participants receive matching placebo (two pills) once daily for 6 months during the randomized, double-blind phase. Participants who do not achieve the primary endpoint at Month 6 may enter a 3-month open-label extension and receive sirolimus 1.5 mg once daily.",[19],"Drug: Placebo",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Sirolimus","Sirolimus 1 mg (two pills) once daily during the 6-month double-blind phase; sirolimus 1.5 mg once daily during the optional 3-month open-label extension for eligible participants.",[9],[27,28],"Rapamycin","mTOR inhibitor",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Placebo","Matching placebo two pills once daily during the 6-month double-blind phase; sirolimus 1.5 mg once daily during the optional 3-month open-label extension for eligible participants.",[15],null,[35],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Lanlan Ji","CONTACT","+86-010-83575130","thigh0829@163.com",[41,59,74,89,104,119,133,142,153,163],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Xiangya Hospital of Central South University","RECRUITING","Changsha","Hunan","410013","China",{"type":49,"coordinates":50},"Point",[51,52],112.97087,28.19874,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":33,"email":58},"Hui Luo","+86-0731-89753999","luohui@csu.edu.cn",{"facility":60,"status":43,"city":61,"state":62,"zip":63,"country":47,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Qilu Hospital of Shandong University","Jinan","Shangdong","250012",{"type":49,"coordinates":65},[66,67],116.99722,36.66833,{"lat":67,"lon":66},[70],{"name":71,"role":37,"phone":72,"phoneExt":33,"email":73},"Qiang Shu","+86-531-8216-9114","shuqiang@sdu.edu.cn",{"facility":75,"status":43,"city":76,"state":77,"zip":78,"country":47,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"West China Hospital, Sichuan University","Chengdu","Sichuan","610041",{"type":49,"coordinates":80},[81,82],104.06667,30.66667,{"lat":82,"lon":81},[85],{"name":86,"role":37,"phone":87,"phoneExt":33,"email":88},"Qibing Xie","+86-028-85422114","xieqibing1971@163.com",{"facility":90,"status":43,"city":91,"state":92,"zip":93,"country":47,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"People's Hospital of Xinjiang Uygur Autonomous Region","Ürümqi","Xinjiang","830001",{"type":49,"coordinates":95},[96,97],87.60046,43.80096,{"lat":97,"lon":96},[100],{"name":101,"role":37,"phone":102,"phoneExt":33,"email":103},"Lijun Wu","+86-991-856-5302","wwlj330@126.com",{"facility":105,"status":43,"city":106,"state":107,"zip":108,"country":47,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"The 1st Affiliated Hospital of Wenzhou Medical University","Wenzhou","Zhejiang","325015",{"type":49,"coordinates":110},[111,112],120.66682,27.99942,{"lat":112,"lon":111},[115],{"name":116,"role":37,"phone":117,"phoneExt":33,"email":118},"Li Sun","+86-0577-55578037","grassandsun@126.com",{"facility":120,"status":43,"city":121,"state":33,"zip":122,"country":47,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Beijing Chao-Yang Hospital","Beijing","100020",{"type":49,"coordinates":124},[125,126],116.39723,39.9075,{"lat":126,"lon":125},[129],{"name":130,"role":37,"phone":131,"phoneExt":33,"email":132},"Juan Meng","+86-010-85231777","mserena@163.com",{"facility":5,"status":43,"city":121,"state":33,"zip":134,"country":47,"cosmosGeoPoint":135,"geoPoint":137,"contacts":138},"100034",{"type":49,"coordinates":136},[125,126],{"lat":126,"lon":125},[139],{"name":140,"role":37,"phone":38,"phoneExt":33,"email":141},"Zhuoli Zhang","zhuoli.zhang@126.com",{"facility":143,"status":43,"city":121,"state":33,"zip":144,"country":47,"cosmosGeoPoint":145,"geoPoint":147,"contacts":148},"Peking University Third Hospital","100083",{"type":49,"coordinates":146},[125,126],{"lat":126,"lon":125},[149],{"name":150,"role":37,"phone":151,"phoneExt":33,"email":152},"Rong Mu","+86-010-82264567","murongster@163.com",{"facility":154,"status":43,"city":121,"state":33,"zip":33,"country":47,"cosmosGeoPoint":155,"geoPoint":157,"contacts":158},"Beijing Shijitan Hospital",{"type":49,"coordinates":156},[125,126],{"lat":126,"lon":125},[159],{"name":160,"role":37,"phone":161,"phoneExt":33,"email":162},"Yuhua Wang","+86-010-63925588","wangyh@bjsjth.cn",{"facility":164,"status":43,"city":165,"state":33,"zip":166,"country":47,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Shanghai Renji Hospital","Shanghai","200001",{"type":49,"coordinates":168},[169,170],121.45806,31.22222,{"lat":170,"lon":169},[173],{"name":174,"role":37,"phone":175,"phoneExt":33,"email":176},"Ting Li","+86-021-5388 2125","leeting007@163.com",{"type":178,"investigatorFullName":179,"investigatorTitle":180,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Zhuoli ZHANG","MD, PhD, Director of Rheumatology and Immunology Department",[182],{"name":183,"class":184},"North China Pharmaceutical Co.,Ltd","UNKNOWN","100571617",false,"NCT06722586","Sirolimus Monotherapy in the Treatment of Antiphospholipid Antibody Related Thrombocytopenia","Sirolimus Monotherapy in the Treatment of Antiphospholipid Antibody Related Thrombocytopenia: a Multicenter Randomized, Double Blind, Placebo Controlled, Clinical Trial","SMART","Inclusion Criteria:\n\n* persistent positive of antiphospholipid antibody (either lupus anticoagulant, anti-cardiolipin antibody, or anti-b2GP1 antibody, at least two times with 12 weeks apart)\n* persistent thrombocytopenia (30-100×10\\^9\u002FL, at least for 2 weeks)\n\nEligible concomitant treatment:\n\n* prednisone or equivalent dose less than 10mg per day is allowed, and dose should be stable for more than 2 weeks\n* hydroxychloroquine less than 400mg per day is allowed, and dose should be stable for more than 1 month\n* anti-platelet and\u002For anti-coagulant therapy is allowed, and strength should be the stable for 1 week\n* these following therapies should be discontinued for more than 5 half-lives before the enrollment, including thrombopoietin or thrombopoietin receptor antagonist, intravenous immunoglobulin, immunosuppressants, B cell inhibitors (Belimumab or Talitacicept) and B cell depletion therapy (Rituximab or Obinutuzumab).\n\nExclusion Criteria:\n\n* fulling the criteria of other connective tissue disease other than antiphospholipid syndrome\n* received oral\u002Fintravenous antibiotics within 2 weeks before the enrollment.\n* new onset of thrombosis within 4 weeks before the enrollment.\n* apparent bleeding tendency.\n* life or organ threatening manifestations, includes but not limit to catastrophic antiphospholipid syndrome and thrombotic microangiopathy.\n* liver and renal dysfunction: ALT or AST more than three times of upper limit of normal range; eGFR\\\u003C40mL\u002Fmin\u002F1.73m\\^2\n* hematocytopenia: WBC\\\u003C3.0×10\\^9\u002FL, Hb\\\u003C100g\u002FL.\n* uncontrollable hyperlipidemia: low density lipoprotein cholesterol\\>3.1 mmol\u002FL, triglycerides\\>2.3 mmol\u002FL after lipid lowering therapy.\n* current active infection\n* women in pregnancy and postpartum period","ALL","18 Years",{"count":195,"type":196},84,"ESTIMATED","INTERVENTIONAL",[199],"PHASE4","The goal of this clinical trial is to evaluate the efficacy and safety of sirolimus in patients with anti-phospholipid antibody-associated thrombocytopenia.\n\nIn the 6-month randomized, double-blind, placebo-controlled phase, participants will receive either sirolimus 1 mg once daily or matching placebo. Participants will be followed at 2 weeks, 1 month, 3 months, and 6 months after enrollment.\n\nParticipants who do not achieve the primary endpoint at 6 months may enter a 3-month open-label extension and receive sirolimus 1.5 mg once daily, with follow-up through month 9.\n\nThe main question is whether sirolimus improves the overall response rate at 6 months compared with placebo.\n\nPrimary outcome:\n\n\\- Overall response rate at 6 months\n\nSecondary outcomes:\n\n* Overall response rate at 1 month and 3 months\n* Complete response rate at 6 months\n* Partial response rate at 6 months\n* Change in anti-phospholipid antibody titers at 6 months\n* Change in oral glucocorticoid dosage at 6 months\n\nExploratory outcomes:\n\n* Proportion and reasons for early discontinuation during the double-blind phase\n* Among participants who do not achieve the primary endpoint at 6 months and enter the open-label extension, overall response rate, complete response rate, partial response rate, and safety outcomes after 3 months of open-label treatment",[202,203],"Antiphospholipid (aPL)-Positive","Thrombocytopaenia",[205,206,207,208,28],"antiphospholipid","thrombocytopaenia","sirolimus","rapamycin","2026-06-25",{"date":211,"type":212},"2026-06-30","ACTUAL",{"date":214,"type":212},"2025-01-07",{"date":216,"type":196},"2027-12",{"name":5,"class":6},10]