[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605203":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":15,"locations":7,"responsibleParty":21,"collaborators":7,"id":23,"slug":24,"hasResults":25,"nctId":26,"briefTitle":27,"officialTitle":28,"acronym":7,"eligibilityCriteria":29,"healthyVolunteers":25,"sex":30,"minAge":7,"maxAge":31,"enrollmentInfo":7,"targetDuration":7,"studyType":32,"phases":7,"briefSummary":33,"conditions":34,"keywords":7,"overallStatus":36,"whyStopped":7,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":41,"locationsCount":7},{"fullName":5,"class":6},"CSL Behring","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"BIOLOGICAL","CSL312","Fully human immunoglobulin G subclass 4\u002Flambda recombinant inhibitor monoclonal antibody administered subcutaneously (SC)",[14],"Garadacimab",[16],{"name":17,"role":18,"phone":19,"phoneExt":7,"email":20},"Trial Registration Coordinator","CONTACT","1-610-878-4697","clinicaltrials@cslbehring.com",{"type":22,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100605203","post-study-access-of-csl312-garadacimab-for-pediatric-participants-with-hereditary-angioedema-who-have-completed-the-csl3123003-study-100605203",false,"NCT07159464","Post Study Access of CSL312 (Garadacimab) for Pediatric Participants With Hereditary Angioedema Who Have Completed the CSL312_3003 Study","Post Study Access of CSL312 (Garadacimab) for the Routine Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Participants (2-11 Years Old) With HAE Who Have Completed the CSL312_3003 Study","Inclusion Criteria:\n\n* Completion of treatment period in study CSL312\\_3003 (NCT05819775)\n* The participant responded to CSL312 treatment with no or very limited number of HAE attacks during the CSL312\\_3003 study\n* The participant experienced no clinically significant adverse effects associated with CSL312 treatment\n* In the opinion of the treating physician, the participant continues to receive benefit from CSL312\n* There is no other suitable alternative prophylactic treatment available at the time of consenting into the Post Study Access program\n\nExclusion Criteria:\n\n* In the opinion of the treating physician, participant may not be compliant with the Protocol requirements\n* Participant is 12 years or older at the time of consent\n* In the opinion of the treating physician, other study medication of prophylaxis treatment of HAE may benefit the participant more than continuing treatment with CSL312\n* Participant who is pregnant, breastfeeding, or not willing to cease breastfeeding","ALL","11 Years","EXPANDED_ACCESS","This protocol for post study access allows pediatric participants (2-11 years old at the time of consent) with HAE who have completed study CSL312\\_3003 (NCT05819775) to continue treatment with CSL312 for routine prevention of HAE attacks. The continuing treatment with the study product will be administered under a Post Study Access program in accordance with the applicable laws and regulations, to be dictated by CSL Behring (Sponsor) and approved by the appropriate local\u002Fcentral Ethics Committees and all other competent authorities required by law, as applicable.",[35],"Hereditary Angioedema (HAE)","AVAILABLE","2025-08-28",{"date":39,"type":40},"2025-09-08","ACTUAL",{"name":5,"class":6}]