[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615887":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":31,"centralContacts":32,"locations":37,"responsibleParty":134,"collaborators":31,"id":136,"slug":137,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":31,"eligibilityCriteria":142,"healthyVolunteers":138,"sex":143,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":31,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":31,"overallStatus":40,"whyStopped":31,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"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",[38,52,61,70,79,88,98,106,114,124],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":31},"Ionis Investigative Site","RECRUITING","Santa Monica","California","90404","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-118.49138,34.01949,{"lat":50,"lon":49},{"facility":39,"status":40,"city":53,"state":54,"zip":55,"country":44,"countryCode":45,"cosmosGeoPoint":56,"geoPoint":60,"contacts":31},"Miami","Florida","33136",{"type":47,"coordinates":57},[58,59],-80.19366,25.77427,{"lat":59,"lon":58},{"facility":39,"status":40,"city":62,"state":63,"zip":64,"country":44,"countryCode":45,"cosmosGeoPoint":65,"geoPoint":69,"contacts":31},"St Louis","Missouri","63141",{"type":47,"coordinates":66},[67,68],-90.19789,38.62727,{"lat":68,"lon":67},{"facility":39,"status":40,"city":71,"state":72,"zip":73,"country":44,"countryCode":45,"cosmosGeoPoint":74,"geoPoint":78,"contacts":31},"Cincinnati","Ohio","45236",{"type":47,"coordinates":75},[76,77],-84.51439,39.12711,{"lat":77,"lon":76},{"facility":39,"status":40,"city":80,"state":81,"zip":82,"country":44,"countryCode":45,"cosmosGeoPoint":83,"geoPoint":87,"contacts":31},"Hershey","Pennsylvania","17033",{"type":47,"coordinates":84},[85,86],-76.65025,40.28592,{"lat":86,"lon":85},{"facility":39,"status":40,"city":89,"state":31,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":97,"contacts":31},"Milan","20157","Italy","IT",{"type":47,"coordinates":94},[95,96],12.59836,42.78235,{"lat":96,"lon":95},{"facility":39,"status":40,"city":99,"state":31,"zip":100,"country":91,"countryCode":92,"cosmosGeoPoint":101,"geoPoint":105,"contacts":31},"Padova","35128",{"type":47,"coordinates":102},[103,104],11.14261,44.38225,{"lat":104,"lon":103},{"facility":39,"status":40,"city":107,"state":31,"zip":108,"country":91,"countryCode":92,"cosmosGeoPoint":109,"geoPoint":113,"contacts":31},"San Donato Milanese","20097",{"type":47,"coordinates":110},[111,112],9.26838,45.41047,{"lat":112,"lon":111},{"facility":39,"status":40,"city":115,"state":31,"zip":116,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":123,"contacts":31},"Warsaw","04-501","Poland","PL",{"type":47,"coordinates":120},[121,122],21.01178,52.22977,{"lat":122,"lon":121},{"facility":39,"status":40,"city":125,"state":31,"zip":126,"country":127,"countryCode":128,"cosmosGeoPoint":129,"geoPoint":133,"contacts":31},"Barcelona","08035","Spain","ES",{"type":47,"coordinates":130},[131,132],2.15899,41.38879,{"lat":132,"lon":131},{"type":135,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100615887","phase-3-donidalorsen-treatment-in-children-with-hereditary-angioedema-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":147,"type":148},20,"ESTIMATED","INTERVENTIONAL",[151],"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).",[154],"Hereditary Angioedema (HAE)","2026-05-27",{"date":157,"type":158},"2026-05-28","ACTUAL",{"date":160,"type":158},"2026-04-21",{"date":162,"type":148},"2029-06",{"name":5,"class":6},10]