[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"thrombocytopenia-immune\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:thrombocytopenia-immune":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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100627928","phase-3-safety-and-efficacy-study-of-ql0911-to-treat-immune-thrombocytopenia-itp-in-pediatric-patients-100627928",false,"NCT07455006","Safety and Efficacy Study of QL0911 to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients","A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of QL0911 in Pediatric Patients With Primary Immune Thrombocytopenia.","Inclusion Criteria:\n\n1. Age ≥ 1 years old and \\\u003C 18 years old.\n2. Diagnosed primary ITP for at least 12 months;\n3. Had received at least one first-line ITP treatment with no response or recurrence after treatment;\n4. Had a platelet count \\\u003C30×10\\^9\u002FL within 48 hours before the first dose;\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;\n6. Patients of child-bearing potential must agree to use effective contraception during the study and for 3 months following the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Had a history of bone marrow stem cell abnormalities or myelodysplastic syndrome other than ITP-specific changes.\n2. Underwent splenectomy within 12 weeks before the first dose;\n3. Had received ITP treatments (including rescue treatment) within 2 weeks before the first dose;\n4. Had received romiplostim (Nplate®) or eltrombopag (Revolade®), rhTPO or other agents that stimulate TPO receptors (also known as c-Mpl)within 4 weeks before the first dose;\n5. Had received antibody-based therapies within 14 weeks before the first dose.\n6. Patients with concurrent or past malignant disease.\n7. Serum creatinine or total bilirubin \\>1.5\\*ULN) alanine transaminase (ALT) or aspartate transaminase (AST) \\>3\\* ULN.\n8. Had received antibody-based therapies within 14 weeks before the first dose.\n9. Had prothrombin time (PT) or prothrombin time-international normalized ratio (PT-INR) or activated partial thromboplastin time (APTT) exceeded 20% of the reference range of normal values.","ALL","1 Year","17 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to evaluate efficacy and of safety QL0911 in the treatment of thrombocytopenia in pediatric patients with previously treated chronic ITP.",[27],"Thrombocytopenia, Immune",[29],"Immune Thrombocytopenia","NOT_YET_RECRUITING","2026-03-02",{"date":33,"type":34},"2026-03-06","ACTUAL",{"date":36,"type":21},"2026-04-20",{"date":38,"type":21},"2028-03-10",{"name":40,"class":41},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY"]