[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615887":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":31,"centralContacts":32,"locations":37,"responsibleParty":130,"collaborators":31,"id":132,"slug":31,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":31,"eligibilityCriteria":137,"healthyVolunteers":133,"sex":138,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":31,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":31,"overallStatus":40,"whyStopped":31,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Ionis Pharmaceuticals, Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Donidalorsen: Group 1","EXPERIMENTAL","Participant weighing 9 kilograms (kg) to less than (\\\u003C)26 kg, will be administered donidalorsen over the period of one year.",[13],"Drug: Donidalorsen",{"label":15,"type":10,"description":16,"interventionNames":17},"Donidalorsen: Group 2","Participant weighing greater than or equal to (≥)26 kg to \\\u003C41 kg, will be administered donidalorsen over the period of one year.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Donidalorsen: Group 3","Participant weighing ≥41kg, will receive donidalorsen over the period of one year.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Donidalorsen","Donidalorsen will be administered by subcutaneous (SC) injection.",[9,15,19],[29,30],"ISIS 721744","IONIS-PKK-LRx",null,[33],{"name":5,"role":34,"phone":35,"phoneExt":31,"email":36},"CONTACT","(844) 201-3192","IonisDonidalorsenPediatric@clinicaltrialmedia.com",[38,51,60,69,78,87,96,104,112,121],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":31},"Ionis Investigative Site","RECRUITING","Santa Monica","California","90404","United States",{"type":46,"coordinates":47},"Point",[48,49],-118.49138,34.01949,{"lat":49,"lon":48},{"facility":39,"status":40,"city":52,"state":53,"zip":54,"country":44,"cosmosGeoPoint":55,"geoPoint":59,"contacts":31},"Miami","Florida","33136",{"type":46,"coordinates":56},[57,58],-80.19366,25.77427,{"lat":58,"lon":57},{"facility":39,"status":40,"city":61,"state":62,"zip":63,"country":44,"cosmosGeoPoint":64,"geoPoint":68,"contacts":31},"St Louis","Missouri","63141",{"type":46,"coordinates":65},[66,67],-90.19789,38.62727,{"lat":67,"lon":66},{"facility":39,"status":40,"city":70,"state":71,"zip":72,"country":44,"cosmosGeoPoint":73,"geoPoint":77,"contacts":31},"Cincinnati","Ohio","45236",{"type":46,"coordinates":74},[75,76],-84.51439,39.12711,{"lat":76,"lon":75},{"facility":39,"status":40,"city":79,"state":80,"zip":81,"country":44,"cosmosGeoPoint":82,"geoPoint":86,"contacts":31},"Hershey","Pennsylvania","17033",{"type":46,"coordinates":83},[84,85],-76.65025,40.28592,{"lat":85,"lon":84},{"facility":39,"status":40,"city":88,"state":31,"zip":89,"country":90,"cosmosGeoPoint":91,"geoPoint":95,"contacts":31},"Milan","20157","Italy",{"type":46,"coordinates":92},[93,94],12.59836,42.78235,{"lat":94,"lon":93},{"facility":39,"status":40,"city":97,"state":31,"zip":98,"country":90,"cosmosGeoPoint":99,"geoPoint":103,"contacts":31},"Padova","35128",{"type":46,"coordinates":100},[101,102],11.14261,44.38225,{"lat":102,"lon":101},{"facility":39,"status":40,"city":105,"state":31,"zip":106,"country":90,"cosmosGeoPoint":107,"geoPoint":111,"contacts":31},"San Donato Milanese","20097",{"type":46,"coordinates":108},[109,110],9.26838,45.41047,{"lat":110,"lon":109},{"facility":39,"status":40,"city":113,"state":31,"zip":114,"country":115,"cosmosGeoPoint":116,"geoPoint":120,"contacts":31},"Warsaw","04-501","Poland",{"type":46,"coordinates":117},[118,119],21.01178,52.22977,{"lat":119,"lon":118},{"facility":39,"status":40,"city":122,"state":31,"zip":123,"country":124,"cosmosGeoPoint":125,"geoPoint":129,"contacts":31},"Barcelona","08035","Spain",{"type":46,"coordinates":126},[127,128],2.15899,41.38879,{"lat":128,"lon":127},{"type":131,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100615887",false,"NCT07298447","Donidalorsen Treatment in Children With Hereditary Angioedema","An Open-Label Study of Donidalorsen in Pediatric Patients Age 2 to Less Than 12 Years Old With Hereditary Angioedema","Key Inclusion Criteria:\n\n1. Must be between the ages of 2 and less than 12 years, inclusive, at the time of informed consent and, as applicable, assent.\n2. Must weigh at least 9 kg at the time of informed consent and, as applicable, assent.\n3. Documented diagnosis of HAE-1\u002FHAE-2 based upon both of the following:\n\n   1. Documented clinical history consistent with HAE (SC or mucosal, non-pruritic swelling episodes without accompanying urticaria).\n   2. Diagnostic testing results that confirm HAE-1\u002FHAE-2: C1-inhibitor (C1-INH) functional level \\\u003C50% normal level AND complement factor C4 level below the lower limit of normal (LLN); OR a known pathogenic mutation in the SERPING1 gene.\n\nKey Exclusion Criteria:\n\n1. Must not have any screening laboratory abnormalities or any other clinically significant abnormalities during screening that would render a participant unsuitable for inclusion.\n2. Must not have been treated with another investigational drug, biological agent, or device within 1 month of Screening, or 5 half-lives of investigational agent, whichever is longer.\n3. Concurrent diagnosis of any other type of recurrent angioedema, including idiopathic angioedema or HAE with normal C1-INH (HAE-nC1-INH or Type III).\n\nNote: Other protocol-specified inclusion\u002Fexclusion criteria may apply.","ALL","2 Years","11 Years",{"count":142,"type":143},20,"ESTIMATED","INTERVENTIONAL",[146],"PHASE3","The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of donidalorsen in pediatric participants with hereditary angioedema (HAE) Type I (HAE-1) or Type II (HAE-2).",[149],"Hereditary Angioedema (HAE)","2026-05-27",{"date":152,"type":153},"2026-05-28","ACTUAL",{"date":155,"type":153},"2026-04-21",{"date":157,"type":143},"2029-06",{"name":5,"class":6},10]