[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627928":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":29,"studyPopulation":29,"armGroups":44,"interventions":57,"overallOfficials":29,"centralContacts":66,"locations":29,"responsibleParty":72,"collaborators":29,"id":74,"slug":29,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":29,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":29,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":94,"whyStopped":29,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":29},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants With a Durable Platelet Response","A participant with durable platelet response was defined as achieving at least 6 weekly platelet counts of ≥ 50 x 10\\^9\u002FL from week 18 to week 25. If a platelet count from a participant was not available (missing) in a certain week, that week was imputed as non-response for that participant. Platelet counts were not deemed as a positive response for 4 weeks after the administration of rescue medication.","Week 18 to week 25",[14,18,21,24,27,31],{"measure":15,"description":16,"timeFrame":17},"Percentage of Participants With an Overall Platelet Response","Overall platelet response is defined as either a durable platelet response or transient platelet response.","24 weeks",{"measure":19,"description":20,"timeFrame":17},"The proportion of subjects with a weekly platelet count ≥ 30 × 10^9\u002FLand at least twice the baseline platelet count without bleeding during the double-blind period of 24 weeks.","The proportion of subjects with a weekly platelet count ≥ 30 × 10\\^9\u002FLand at least twice the baseline platelet count without bleeding during the double-blind period of 24 weeks.",{"measure":22,"description":23,"timeFrame":17},"Number of Weeks With Platelet Response","Number of weeks with platelet counts ≥ 50 x 10\\^9\u002FL.",{"measure":25,"description":26,"timeFrame":17},"Percentage of Participants Who Received Rescue Medication During the Treatment Period.","Rescue medication is any medication that is intended to increase platelet counts or prevent bleeding.",{"measure":28,"description":29,"timeFrame":30},"Number of Participants With Treatment-emergent Adverse Events (TEAEs)",null,"Up to Week 38",{"measure":32,"description":29,"timeFrame":30},"Number of Participants With Antidrug Antibodies (ADAs) , Anti endogenous TPO antibody and Neutralizing Antibodies (Nab)；",{"allocation":34,"interventionModel":35,"interventionModelDescription":29,"primaryPurpose":36,"observationalModel":29,"timePerspective":29,"maskingInfo":37},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":38,"maskingDescription":29,"whoMasked":39},"QUADRUPLE",[40,41,42,43],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[45,51],{"label":46,"type":47,"description":48,"interventionNames":49},"QL0911","EXPERIMENTAL","Participants received once weekly subcutaneous QL0911 at a starting dose of 1 µg\u002Fkg; weekly dose increases continued in increments of 1 µg\u002Fkg\u002Fweek to a maximum dose of 10 µg\u002Fkg in an attempt to reach a target platelet count of ≥ 50 x 10\\^9\u002FL.",[50],"Drug: QL0911",{"label":52,"type":53,"description":54,"interventionNames":55},"placebo","PLACEBO_COMPARATOR","Participants received weekly subcutaneous placebo.",[56],"Drug: Placebo",[58,62],{"type":59,"name":46,"description":60,"armGroupLabels":61,"otherNames":29},"DRUG","The starting dose of QL0911 is 1 µg\u002Fkg administered weekly by subcutaneous injection. Participants will return to the clinic weekly to provide platelet counts and undergo dose titrations under the supervision of the treating physician. Weekly dose increases will continue in increments of 1 µg\u002Fkg up to a maximum dose of 10 µg\u002Fkg in an attempt to reach a target platelet count of ≥ 50 x 10\\^9\u002FL. Dose adjustment will be allowed during the treatment period to maintain a platelet count between ≥ 50 x 10\\^9\u002FL and ≤ 200 x 10\\^9\u002FL.",[46],{"type":59,"name":63,"description":64,"armGroupLabels":65,"otherNames":29},"Placebo","Matching placebo administered by subcutaneous injection.",[52],[67],{"name":68,"role":69,"phone":70,"phoneExt":29,"email":71},"Run hui Wu, Doctorate","CONTACT","13370115037","wurunhuigcp@163.com",{"type":73,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","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":84,"type":85},60,"ESTIMATED","INTERVENTIONAL",[88],"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.",[91],"Thrombocytopenia, Immune",[93],"Immune Thrombocytopenia","NOT_YET_RECRUITING","2026-03-02",{"date":97,"type":98},"2026-03-06","ACTUAL",{"date":100,"type":85},"2026-04-20",{"date":102,"type":85},"2028-03-10",{"name":5,"class":6}]