[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607922":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":180,"collaborators":25,"id":182,"slug":183,"hasResults":184,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":25,"eligibilityCriteria":188,"healthyVolunteers":184,"sex":189,"minAge":190,"maxAge":191,"enrollmentInfo":192,"targetDuration":25,"studyType":195,"phases":196,"briefSummary":199,"conditions":200,"keywords":25,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},{"fullName":5,"class":6},"argenx","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Efgartigimod IV","EXPERIMENTAL","Participants receiving efgartigimod IV during the double-blinded treatment period and the open-label treatment period(s)",[13],"Biological: Efgartigimod IV",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo IV","PLACEBO_COMPARATOR","Participants receiving placebo IV during the double-blinded treatment period and receiving efgartigimod IV during the open-label treatment period(s)",[13,19],"Other: Placebo IV",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Intravenous infusion of efgartigimod",[9,15],null,{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":25},"OTHER","Intravenous infusion of placebo",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Sabine Coppieters, MD","CONTACT","857-350-4834","clinicaltrials@argenx.com",[37,54,70,80,96,112,128,142,156,166],{"facility":38,"status":39,"city":40,"state":25,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)","RECRUITING","Berlin","13353","Germany","DE",{"type":45,"coordinates":46},"Point",[47,48],13.41053,52.52437,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":53,"phoneExt":25,"email":35},"Susanne Holzhauer, MD","+1 857-350-4834",{"facility":55,"status":39,"city":56,"state":25,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Gaslini Children's Hospital","Genoa","16147","Italy","IT",{"type":45,"coordinates":61},[62,63],8.94439,44.40478,{"lat":63,"lon":62},[66],{"name":67,"role":33,"phone":68,"phoneExt":25,"email":69},"Maurizio Miano, MD","+3901056363683","mauriziomiano@gaslini.org",{"facility":71,"status":72,"city":73,"state":25,"zip":74,"country":58,"countryCode":59,"cosmosGeoPoint":75,"geoPoint":79,"contacts":25},"Bambino Gesu Children's Hospital","ACTIVE_NOT_RECRUITING","Roma","165",{"type":45,"coordinates":76},[77,78],11.10642,44.99364,{"lat":78,"lon":77},{"facility":81,"status":39,"city":82,"state":25,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Uniwersytecki Szpital Dzieciecy w Lublinie","Lublin","20-093","Poland","PL",{"type":45,"coordinates":87},[88,89],22.57009,51.25058,{"lat":89,"lon":88},[92],{"name":93,"role":33,"phone":94,"phoneExt":25,"email":95},"Katarzyna Drabko, MD","+48606729876","katarzyna.drabko@umlub.pl",{"facility":97,"status":39,"city":98,"state":25,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Institutul Clinic Fundeni","Bucharest","022328","Romania","RO",{"type":45,"coordinates":103},[104,105],26.10626,44.43225,{"lat":105,"lon":104},[108],{"name":109,"role":33,"phone":110,"phoneExt":25,"email":111},"Anca Colita, MD","+40213172194","secretariat@icfundeni.ro",{"facility":113,"status":39,"city":114,"state":25,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Hospital Universitari Vall d'Hebron","Barcelona","08035","Spain","ES",{"type":45,"coordinates":119},[120,121],2.15899,41.38879,{"lat":121,"lon":120},[124],{"name":125,"role":33,"phone":126,"phoneExt":25,"email":127},"Thais Murciano Carrillo, MD","0034934893093","thais.murciano@vallhebron.cat",{"facility":129,"status":39,"city":130,"state":25,"zip":131,"country":116,"countryCode":117,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Hospital Sant Joan de Deu Barcelona","Esplugues de Llobregat","08950",{"type":45,"coordinates":133},[134,135],2.08809,41.37732,{"lat":135,"lon":134},[138],{"name":139,"role":33,"phone":140,"phoneExt":25,"email":141},"Ruben Berrueco Moreno, MD","0034936009733","ruben.berrueco@sjd.es",{"facility":143,"status":39,"city":144,"state":25,"zip":145,"country":116,"countryCode":117,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Hospital Infantil Universitario Nino Jesus (HIUNJS)","Madrid","28009",{"type":45,"coordinates":147},[148,149],-3.70256,40.4165,{"lat":149,"lon":148},[152],{"name":153,"role":33,"phone":154,"phoneExt":25,"email":155},"Julian Sevilla Navarro, MD","0034915036900","julian.sevilla@salud.madrid.org",{"facility":157,"status":39,"city":144,"state":25,"zip":145,"country":116,"countryCode":117,"cosmosGeoPoint":158,"geoPoint":160,"contacts":161},"Hospital Materno-Infantil Universitario Gregorio Maranon",{"type":45,"coordinates":159},[148,149],{"lat":149,"lon":148},[162],{"name":163,"role":33,"phone":164,"phoneExt":25,"email":165},"David Diaz Perez, MD","0037915290037","ddiazp@salud.madrid.org",{"facility":167,"status":39,"city":168,"state":25,"zip":169,"country":170,"countryCode":171,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Cardiff and Vale NHS Trust - University Hospital of Wales (UHW)","Cardiff","CF14 4XW","United Kingdom","UK",{"type":45,"coordinates":173},[174,175],-3.18,51.48,{"lat":175,"lon":174},[178],{"name":179,"role":33,"phone":34,"phoneExt":25,"email":35},"Philip Connor, MD",{"type":181,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":193,"type":194},24,"ESTIMATED","INTERVENTIONAL",[197,198],"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",[201,202,203,204,205,206,207],"Immune Thrombocytopenia (ITP)","ITP - Immune Thrombocytopenia","ITP","Immune Thrombocytopenic Purpura","Immune Thrombocytopenic Purpura ( ITP )","Idiopathic Thrombocytopenic Purpura","Idiopathic Thrombocytopenic Purpura (ITP)","2026-06-11",{"date":210,"type":211},"2026-06-12","ACTUAL",{"date":213,"type":211},"2025-10-20",{"date":215,"type":194},"2030-10",{"name":5,"class":6},10]