[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"itp\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:itp":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,74],{"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":26,"conditions":27,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100607922","phase-2-a-study-of-efgartigimod-iv-in-participants-from-12-years-to-less-than-18-years-of-age-with-chronic-immune-thrombocytopenia-itp-100607922",false,"NCT07194850","A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)","A Multicenter, Randomized, Double-blinded, Parallel-Arm, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study Followed by an Open-Label Arm to Evaluate Efgartigimod IV in Pediatric Participants From 12 Years to Less Than 18 Years of Age With Chronic ITP","Inclusion Criteria:\n\n* Is aged 12 to less than 18 years when completing the informed consent process\n* Has a documented duration of primary ITP of more than 12 months on the date the informed consent process is complete\n* Has documented prior ITP treatment with at least 1 of the following treatments: corticosteroids, IVIg, anti-D immunoglobulin, thrombopoietin receptor agonist (TPO-RAs), or rituximab.\n* Has documented prior response, defined as 1 platelet count of ≥50 × 10\\^9\u002FL to at least 1 of the following ITP treatments: prednisone, other or nonspecified corticosteroids, IVIg, or anti-D immunoglobulin\n* Has documented insufficient response to a prior ITP treatment with corticosteroids, IVIg, anti-D immunoglobulin, TPO-RAs, rituximab, or splenectomy\n* Has documented mean platelet count of less than 30 x10\\^9\u002FL\n\nExclusion Criteria:\n\n* Secondary ITP according to the following definition by the International Working Group (IWG): all forms of immune-mediated thrombocytopenia except primary ITP\n* Nonimmune thrombocytopenia\n* ITP-associated critical or severe bleeding\n* History of hereditary thrombocytopenia","ALL","12 Years","17 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","The main purpose of this study is to confirm the correct dose of efgartigimod IV for treating patients aged 12 to younger than 18 years with chronic immune thrombocytopenia (ITP).\n\nThe study consists of a double-blinded treatment period (DBTP) in which the participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV. At the end of the treatment period (up to 24 weeks), all participants will receive efgartigimod IV during the first year open-label treatment period (OLTP1). At the end of the first OLTP1, participants may begin a second year (OLTP2). After the OLTP2, the participants will enter a follow-up period (approximately 8 weeks) while off study drug. The participants will be in the study for up to 138 weeks.\n\nMore information can be found here: https:\u002F\u002Fclinicaltrials.argenx.com\u002Fadvancejunior",[28,29,30,31,32,33,34],"Immune Thrombocytopenia (ITP)","ITP - Immune Thrombocytopenia","ITP","Immune Thrombocytopenic Purpura","Immune Thrombocytopenic Purpura ( ITP )","Idiopathic Thrombocytopenic Purpura","Idiopathic Thrombocytopenic Purpura (ITP)","RECRUITING","2026-06-11",{"date":38,"type":39},"2026-06-12","ACTUAL",{"date":41,"type":39},"2025-10-20",{"date":43,"type":21},"2030-10",{"name":45,"class":46},"argenx","INDUSTRY",10,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100596322","phase-1-a-phase-1b2a-study-of-budoprutug-in-subjects-with-immune-thrombocytopenia-itp-100596322","NCT07043946","A Phase 1b\u002F2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)","A Phase 1b\u002F2a, Open-Label, Sequential-Cohort, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Effectiveness of Budoprutug (TNT119) in Subjects With Immune Thrombocytopenia (ITP)","Inclusion Criteria:\n\n1. Aged 18 years at the time of consent.\n2. Platelet count \\\u003C 30,000\u002FµL despite an adequate trial of at least one prior therapeutic attempt. Platelet counts of \\\u003C 30,000\u002FµL must be confirmed on 2 occasions at least 5 days apart, but no more than 14 days apart.\n3. Partial thromboplastin time \\\u003C 1.5 x upper limit of normal (ULN), prothrombin time \\\u003C 1.5 x ULN, total bilirubin \\\u003C 1.5 x ULN unless due to Gilbert's syndrome, or an international normalized ratio \\\u003C 1.5 at screening.\n\nExclusion Criteria:\n\n1. CD19+ B cell count \\\u003C 80 cells\u002FµL at Screening, or \\\u003C 40 cells\u002FµL if B-cell depleting therapy was received within 24 weeks to 2 years prior.\n2. Diagnosis of paroxysmal nocturnal hemoglobinuria, Evan's Syndrome, or other bleeding disorders affecting safety or data integrity.\n3. Prior B-cell depleting therapy (e.g., rituximab) within 24 weeks before first dose or planned during the study.\n4. Chronic use of anticoagulants or antiplatelet agents (e.g., aspirin, NSAIDs, thienopyridines) within 14 days before dosing through follow-up. Intermittent NSAID use is allowed.\n5. Immunosuppressants (excluding corticosteroids) within 30 days or 5× half-life before Screening; alkylating agents within 180 days.\n6. IVIg treatment within 90 days prior to Screening.\n7. Active ITP treatment (other than steroids or TPO agonists) within 30 days or 5× half-life before first dose, unless approved by Medical Monitor.\n8. Active, chronic, or latent infections including hepatitis B\u002FC or HIV.\n9. Active TB or high TB risk.","18 Years",{"count":20,"type":21},[58,24],"PHASE1","The main objective is to assess the safety and tolerability of budoprutug in adults with ITP. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.",[28,30,61,62,63],"Biologics","Monoclonal","Anti-CD19","2026-03-24",{"date":66,"type":39},"2026-03-27",{"date":68,"type":39},"2025-06-30",{"date":70,"type":21},"2028-08",{"name":72,"class":46},"Climb Bio, Inc.",20,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":55,"enrollmentInfo":80,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":4},"100609395","safety-and-efficacy-of-romiplostim-in-treatment-of-chronic-itp-in-children-100609395","NCT07214025","Safety and Efficacy of Romiplostim in Treatment of Chronic ITP in Children","Inclusion Criteria:\n\n* Patients aged between 1 and 18 years\n* Diagnosis of chronic ITP\n* Refractory to or intolerant of first-line therapies (e.g.corticosteroids , intravenous immunoglobulin \\[ IVIG \\] , and oral eltrombopag )\n* Platelet count\\\u003C30,000\u002FµL, or evidence of bleeding or risk of bleeding with platelet count\\\u003C50,000\u002FµL.\n* Written informed consent (or parental\u002Fguardian consent for minors)\n\nExclusion Criteria:\n\n* Evidence of secondary thrombocytopenia (e.g., HIV, HCV, systemic lupus erythematosus)\n* congenital thrombocytopenia\n* Age \\\u003C 1year or more than 18 years\n* Aplastic anemia\n* Known hypersensitivity to romiplostim or any of its components",{"count":81,"type":21},100,"OBSERVATIONAL","The aim is to evaluate safety and efficacy of Romiplostim in the treatment of chronic ITP in children",[85,30],"Romiplostim N01","NOT_YET_RECRUITING","2025-10-02",{"date":89,"type":39},"2025-10-09",{"date":91,"type":21},"2025-11-01",{"date":93,"type":21},"2027-01-01",{"name":95,"class":96},"Assiut University","OTHER"]