[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554848":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":25,"responsibleParty":41,"collaborators":25,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":25,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":25,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":65,"whyStopped":25,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":25},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sirolimus","EXPERIMENTAL","Sirolimus 1.5mg po. QD",[13],"Drug: Sirolimus",{"label":15,"type":16,"description":17,"interventionNames":18},"placeobo","PLACEBO_COMPARATOR","Sirolimus placebo 1.5mg po. QD",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Subjects will receive Sirolimus 1.5mg\u002Fd for 48 weeks in addition to their ongoing APS treatment regimen",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo","Subjects will receive Placebo 1.5mg\u002Fd for first 24 weeks and Sirolimus 1.5mg\u002Fd for next 24 weeks in addition to their ongoing APS treatment regimen",[15],[31],{"name":32,"affiliation":33,"role":34},"Zhanguo Li","Peking university peoples hospital","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Liling Xu, Ph.D","CONTACT","+86 010 88324173","xuliling1079@163.com",{"type":42,"investigatorFullName":32,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Department of Rheumatology and immunology","100554848","phase-2-the-safety-and-efficiency-of-sirolimus-in-primary-antiphospholipid-syndrome-a-randomized-control-study-100554848",false,"NCT06504420","The Safety and Efficiency of Sirolimus in Primary Antiphospholipid Syndrome: a Randomized Control Study","A Randomized, Multicenter, Double-blind, Placeobo-control Study of Sirolimus for Primary Antiphospholipid Syndrome Patients","Inclusion Criteria:\n\n1. Understand and sign the informed consent form\n2. Male or Female\n3. aged 18-70 at the time of screening visit\n4. Met 2006 Sapporo classification criteria of APS or 2023 ACR\u002FEULAR classification criteria of APS\n5. With the stable combination therapy\n\nExclusion Criteria:\n\n1. history of serious adverse events or contraindication to Sirolimus\n2. Catastrophic APS within 90 days\n3. Acute thrombosis within 30 days\n4. ≥4\u002F11 American College of Rheumatology Classification Criteria for SLE or other systemic autoimmune diseases\n5. Historically positive HIV test or test positive at screening for HIV\n6. currently on any suppressive therapy for a chronic infection (such as tuberculosis, hepatitis B infection, hepatitis C infection, CMV, EBV, Syphilis, etc)\n7. Surgery treatment within one month\n8. History of malignant neoplasm within the last 5 years\n9. White blood cell counts\\\u003C3×10\\*9\u002FL\n10. Abnormal Liver function tests: ALT or AST ≥ 1.5 times the upper limit of the normal value, and total bilirubin and blood lipids ≥ 2 times the upper limit of the normal value\n11. Pregnant or pregnancy preparation or breastfeed\n12. Any circumstances that may cause the subjects to be unable to complete the study or pose significant risks to the subjects","ALL","18 Years","70 Years",{"count":55,"type":56},70,"ESTIMATED","INTERVENTIONAL",[59],"PHASE2","This study is an Investigator initiated, randomized, multicenter, double-blind, placebo-control study. The aim of this study is to evaluate the safety and efficiency of Sirolimus for primaty antiphospholipid syndrome patients at week 24 and week 48.",[62],"Primary Antiphospholipid Syndrome",[64],"APS","NOT_YET_RECRUITING","2024-09-03",{"date":68,"type":69},"2024-09-19","ACTUAL",{"date":71,"type":56},"2024-10-15",{"date":73,"type":56},"2027-12-30",{"name":5,"class":6}]