[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571617":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":34,"locations":40,"responsibleParty":178,"collaborators":182,"id":186,"slug":187,"hasResults":188,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":188,"sex":194,"minAge":195,"maxAge":33,"enrollmentInfo":196,"targetDuration":33,"studyType":199,"phases":200,"briefSummary":202,"conditions":203,"keywords":206,"overallStatus":43,"whyStopped":33,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},{"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",[41,60,75,90,105,120,134,143,154,164],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Xiangya Hospital of Central South University","RECRUITING","Changsha","Hunan","410013","China","CN",{"type":50,"coordinates":51},"Point",[52,53],112.97087,28.19874,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":58,"phoneExt":33,"email":59},"Hui Luo","+86-0731-89753999","luohui@csu.edu.cn",{"facility":61,"status":43,"city":62,"state":63,"zip":64,"country":47,"countryCode":48,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Qilu Hospital of Shandong University","Jinan","Shangdong","250012",{"type":50,"coordinates":66},[67,68],116.99722,36.66833,{"lat":68,"lon":67},[71],{"name":72,"role":37,"phone":73,"phoneExt":33,"email":74},"Qiang Shu","+86-531-8216-9114","shuqiang@sdu.edu.cn",{"facility":76,"status":43,"city":77,"state":78,"zip":79,"country":47,"countryCode":48,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"West China Hospital, Sichuan University","Chengdu","Sichuan","610041",{"type":50,"coordinates":81},[82,83],104.06667,30.66667,{"lat":83,"lon":82},[86],{"name":87,"role":37,"phone":88,"phoneExt":33,"email":89},"Qibing Xie","+86-028-85422114","xieqibing1971@163.com",{"facility":91,"status":43,"city":92,"state":93,"zip":94,"country":47,"countryCode":48,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"People's Hospital of Xinjiang Uygur Autonomous Region","Ürümqi","Xinjiang","830001",{"type":50,"coordinates":96},[97,98],87.60046,43.80096,{"lat":98,"lon":97},[101],{"name":102,"role":37,"phone":103,"phoneExt":33,"email":104},"Lijun Wu","+86-991-856-5302","wwlj330@126.com",{"facility":106,"status":43,"city":107,"state":108,"zip":109,"country":47,"countryCode":48,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"The 1st Affiliated Hospital of Wenzhou Medical University","Wenzhou","Zhejiang","325015",{"type":50,"coordinates":111},[112,113],120.66682,27.99942,{"lat":113,"lon":112},[116],{"name":117,"role":37,"phone":118,"phoneExt":33,"email":119},"Li Sun","+86-0577-55578037","grassandsun@126.com",{"facility":121,"status":43,"city":122,"state":33,"zip":123,"country":47,"countryCode":48,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Beijing Chao-Yang Hospital","Beijing","100020",{"type":50,"coordinates":125},[126,127],116.39723,39.9075,{"lat":127,"lon":126},[130],{"name":131,"role":37,"phone":132,"phoneExt":33,"email":133},"Juan Meng","+86-010-85231777","mserena@163.com",{"facility":5,"status":43,"city":122,"state":33,"zip":135,"country":47,"countryCode":48,"cosmosGeoPoint":136,"geoPoint":138,"contacts":139},"100034",{"type":50,"coordinates":137},[126,127],{"lat":127,"lon":126},[140],{"name":141,"role":37,"phone":38,"phoneExt":33,"email":142},"Zhuoli Zhang","zhuoli.zhang@126.com",{"facility":144,"status":43,"city":122,"state":33,"zip":145,"country":47,"countryCode":48,"cosmosGeoPoint":146,"geoPoint":148,"contacts":149},"Peking University Third Hospital","100083",{"type":50,"coordinates":147},[126,127],{"lat":127,"lon":126},[150],{"name":151,"role":37,"phone":152,"phoneExt":33,"email":153},"Rong Mu","+86-010-82264567","murongster@163.com",{"facility":155,"status":43,"city":122,"state":33,"zip":33,"country":47,"countryCode":48,"cosmosGeoPoint":156,"geoPoint":158,"contacts":159},"Beijing Shijitan Hospital",{"type":50,"coordinates":157},[126,127],{"lat":127,"lon":126},[160],{"name":161,"role":37,"phone":162,"phoneExt":33,"email":163},"Yuhua Wang","+86-010-63925588","wangyh@bjsjth.cn",{"facility":165,"status":43,"city":166,"state":33,"zip":167,"country":47,"countryCode":48,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Shanghai Renji Hospital","Shanghai","200001",{"type":50,"coordinates":169},[170,171],121.45806,31.22222,{"lat":171,"lon":170},[174],{"name":175,"role":37,"phone":176,"phoneExt":33,"email":177},"Ting Li","+86-021-5388 2125","leeting007@163.com",{"type":179,"investigatorFullName":180,"investigatorTitle":181,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Zhuoli ZHANG","MD, PhD, Director of Rheumatology and Immunology Department",[183],{"name":184,"class":185},"North China Pharmaceutical Co.,Ltd","UNKNOWN","100571617","phase-4-sirolimus-monotherapy-in-the-treatment-of-antiphospholipid-antibody-related-thrombocytopenia-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":197,"type":198},84,"ESTIMATED","INTERVENTIONAL",[201],"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",[204,205],"Antiphospholipid (aPL)-Positive","Thrombocytopaenia",[207,208,209,210,28],"antiphospholipid","thrombocytopaenia","sirolimus","rapamycin","2026-06-25",{"date":213,"type":214},"2026-06-30","ACTUAL",{"date":216,"type":214},"2025-01-07",{"date":218,"type":198},"2027-12",{"name":5,"class":6},10]