[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"antiphospholipid-apl-positive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:antiphospholipid-apl-positive":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":20,"type":21},84,"ESTIMATED","INTERVENTIONAL",[24],"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",[27,28],"Antiphospholipid (aPL)-Positive","Thrombocytopaenia",[30,31,32,33,34],"antiphospholipid","thrombocytopaenia","sirolimus","rapamycin","mTOR inhibitor","RECRUITING","2026-06-25",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":39},"2025-01-07",{"date":43,"type":21},"2027-12",{"name":45,"class":46},"Peking University First Hospital","OTHER",10]