[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548012":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":16,"locations":7,"responsibleParty":22,"collaborators":7,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":29,"acronym":7,"eligibilityCriteria":30,"healthyVolunteers":26,"sex":31,"minAge":32,"maxAge":7,"enrollmentInfo":7,"targetDuration":7,"studyType":33,"phases":7,"briefSummary":34,"conditions":35,"keywords":37,"overallStatus":39,"whyStopped":7,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":44,"locationsCount":7},{"fullName":5,"class":6},"Ionis Pharmaceuticals, Inc.","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DRUG","Donidalorsen","Donidalorsen administered once monthly or every other month by subcutaneous (SC) injections in the abdomen, thigh, or upper arm.",[14,15],"IONIS PKK-LRx","ISIS 721744",[17],{"name":18,"role":19,"phone":20,"phoneExt":7,"email":21},"Ionis Pharmaceuticals Medical Information","CONTACT","1-833-644-6647 (833-MI-IONIS)","MedInfo@ionisph.com",{"type":23,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100548012","donidalorsen-expanded-access-program-for-patients-with-hereditary-angioedema-100548012",false,"NCT06415448","Donidalorsen Expanded Access Program for Patients With Hereditary Angioedema","Donidalorsen Expanded Access Program for Patients With Hereditary Angioedema (HAE)","Inclusion Criteria:\n\n* Patients in the ISIS 721744-CS3 (Open-Label Extension \\[OLE\\] Study) who have completed 205 weeks of treatment.\n* Female patients of childbearing potential, and male patients with partners of childbearing potential must be willing to use acceptable contraception, or refrain from sexual activity.\n\nExclusion Criteria:\n\n* Any patient who is pregnant or plans to become pregnant.\n* Any patient who was withdrawn from the ISIS 721744-CS3 OLE study due to a serious adverse event (SAE) related to donidalorsen therapy or who voluntarily withdrew prior to 205 weeks of treatment.","ALL","18 Years","EXPANDED_ACCESS","The purpose of the Expanded Access Program is to provide pre-approval access of donidalorsen to eligible patients with Hereditary Angioedema (HAE) who complete the ISIS 721744-CS3 clinical trial.",[36],"Hereditary Angioedema",[38,14,11,15],"HAE","AVAILABLE","2025-07-09",{"date":42,"type":43},"2025-07-11","ACTUAL",{"name":5,"class":6}]