[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593041":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":16,"studyPopulation":31,"armGroups":32,"interventions":38,"overallOfficials":44,"centralContacts":48,"locations":54,"responsibleParty":280,"collaborators":16,"id":282,"slug":16,"hasResults":283,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":283,"sex":289,"minAge":290,"maxAge":16,"enrollmentInfo":291,"targetDuration":16,"studyType":294,"phases":16,"briefSummary":295,"conditions":296,"keywords":298,"overallStatus":57,"whyStopped":16,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":312},{"fullName":5,"class":6},"CSL Behring","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence Rate Ratio (IRR) of HAE Attacks","Monthly HAE attack rate while on treatment with garadacimab, including all HAE attacks, HAE attacks requiring acute treatment (on demand therapy \\[ODT\\]), and by severity will be reported. All HAE attacks will be categorized by severity as: Mild (no impact on daily life), Moderate (some impact on daily life), and Severe (severe impact on daily life).","Up to 24 months",[14,18,22,25],{"measure":15,"description":16,"timeFrame":17},"Number of Participants with Adverse Events (AEs), Severity of AEs, Serious AEs (SAEs), and Treatment-related AEs",null,"Up to 48 months",{"measure":19,"description":20,"timeFrame":21},"Change From Baseline in Angioedema Control Test (AECT) Total Score","The AECT includes a set of 4 AECT items attributable to the domains of signs and symptoms, impact and effectiveness of treatment, and the 4th item addresses the important aspect of unpredictability, which correlates strongly with anxiety and fears of recurrent angioedema patients. Score ranges from 0 (minimum) to 16 (maximum). A higher score indicates a higher level of angioedema control.","Baseline to 48 months",{"measure":23,"description":24,"timeFrame":21},"Change From Baseline in Angioedema Quality of Life Questionnaire (AE-QoL) Total Score","The AE-QoL includes 17 items across 4 domains: functioning (4 items), fatigue\u002Fmood (5 items), fears\u002Fshame (6 items), and food (2 items). Total scores range from 0 to 100, where 100 indicates the worst possible impairment of health related QoL.",{"measure":26,"description":16,"timeFrame":27},"Percentage of Participants With Reduction in Monthly HAE Attacks and who Achieved HAE Attack-free Status","Up to Month 24",{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":29,"timePerspective":30,"maskingInfo":16},"COHORT","PROSPECTIVE","Participants with the diagnosis of HAE and who will initiate garadacimab treatment per routine clinical practice will be enrolled.",[33],{"label":34,"type":16,"description":35,"interventionNames":36},"Garadacimab","This cohort will include all participants diagnosed with HAE and who will be prescribed garadacimab treatment as per routine clinical practice.",[37],"Other: No intervention",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":16},"OTHER","No intervention","No intervention will be administered as part of this study.",[34],[45],{"name":46,"affiliation":5,"role":47},"Global Program Director","STUDY_DIRECTOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":16,"email":53},"Trial Registration Coordinator","CONTACT","+1 610-878-4697","clinicaltrials@cslbehring.com",[55,69,79,84,95,106,116,126,137,149,161,171,181,191,196,208,220,230,240,250,260,270],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":16},"Medical Research of Arizona","RECRUITING","Phoenix","Arizona","85248","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-112.07404,33.44838,{"lat":67,"lon":66},{"facility":70,"status":57,"city":71,"state":72,"zip":73,"country":61,"countryCode":62,"cosmosGeoPoint":74,"geoPoint":78,"contacts":16},"Sirven and Associates","Miami","Florida","33183",{"type":64,"coordinates":75},[76,77],-80.19366,25.77427,{"lat":77,"lon":76},{"facility":80,"status":57,"city":81,"state":82,"zip":83,"country":61,"countryCode":62,"cosmosGeoPoint":16,"geoPoint":16,"contacts":16},"Asthma and Allergy Wellness Center","Saint Charles","Illinois","60175-4827",{"facility":85,"status":86,"city":87,"state":88,"zip":89,"country":61,"countryCode":62,"cosmosGeoPoint":90,"geoPoint":94,"contacts":16},"Family Allergy and Asthma","NOT_YET_RECRUITING","Louisville","Kentucky","40217",{"type":64,"coordinates":91},[92,93],-85.75941,38.25424,{"lat":93,"lon":92},{"facility":96,"status":97,"city":98,"state":99,"zip":100,"country":61,"countryCode":62,"cosmosGeoPoint":101,"geoPoint":105,"contacts":16},"John Hopkins University","ACTIVE_NOT_RECRUITING","Baltimore","Maryland","21287",{"type":64,"coordinates":102},[103,104],-76.61219,39.29038,{"lat":104,"lon":103},{"facility":107,"status":97,"city":108,"state":109,"zip":110,"country":61,"countryCode":62,"cosmosGeoPoint":111,"geoPoint":115,"contacts":16},"Washington University","St Louis","Missouri","63141",{"type":64,"coordinates":112},[113,114],-90.19789,38.62727,{"lat":114,"lon":113},{"facility":117,"status":57,"city":118,"state":119,"zip":120,"country":61,"countryCode":62,"cosmosGeoPoint":121,"geoPoint":125,"contacts":16},"Riverside Medical Group, Belleville","Belleville","New Jersey","07109",{"type":64,"coordinates":122},[123,124],-74.15014,40.79371,{"lat":124,"lon":123},{"facility":127,"status":57,"city":128,"state":16,"zip":129,"country":130,"countryCode":131,"cosmosGeoPoint":132,"geoPoint":136,"contacts":16},"Kepler Universitätsklinikum - Med Campus III.","Linz","4021","Austria","AT",{"type":64,"coordinates":133},[134,135],14.28611,48.30639,{"lat":135,"lon":134},{"facility":138,"status":57,"city":139,"state":140,"zip":141,"country":142,"countryCode":143,"cosmosGeoPoint":144,"geoPoint":148,"contacts":16},"Providence Health Care Society","Vancouver","British Columbia","V6Z 2K5","Canada","CA",{"type":64,"coordinates":145},[146,147],-123.11934,49.24966,{"lat":147,"lon":146},{"facility":150,"status":57,"city":151,"state":152,"zip":153,"country":154,"countryCode":155,"cosmosGeoPoint":156,"geoPoint":160,"contacts":16},"Universitaetsklinikum Ulm","Ulm","Baden-Wurttemberg","89081","Germany","DE",{"type":64,"coordinates":157},[158,159],9.99155,48.39841,{"lat":159,"lon":158},{"facility":162,"status":97,"city":163,"state":164,"zip":165,"country":154,"countryCode":155,"cosmosGeoPoint":166,"geoPoint":170,"contacts":16},"HZRM Haemophilie-Zentrum Rhein Main","Frankfurt am Main","Hesse","60596",{"type":64,"coordinates":167},[168,169],8.68417,50.11552,{"lat":169,"lon":168},{"facility":172,"status":97,"city":173,"state":174,"zip":175,"country":154,"countryCode":155,"cosmosGeoPoint":176,"geoPoint":180,"contacts":16},"Medizinische Hochschule Hannover","Hanover","Lower Saxony","30625",{"type":64,"coordinates":177},[178,179],9.73322,52.37052,{"lat":179,"lon":178},{"facility":182,"status":57,"city":183,"state":184,"zip":185,"country":154,"countryCode":155,"cosmosGeoPoint":186,"geoPoint":190,"contacts":16},"Universitaetsklinikum Carl Gustav Carus TU Dresden","Leipzig","Saxony","01307",{"type":64,"coordinates":187},[188,189],12.37129,51.33962,{"lat":189,"lon":188},{"facility":192,"status":57,"city":193,"state":194,"zip":195,"country":154,"countryCode":155,"cosmosGeoPoint":16,"geoPoint":16,"contacts":16},"Universitaetsklinikum Schleswig Holstein - Campus Luebeck","Hamburg","Schleswig-Holstein","23538",{"facility":197,"status":57,"city":198,"state":16,"zip":199,"country":154,"countryCode":155,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"Charité - Campus Charité Mitte","Berlin","10117",{"type":64,"coordinates":201},[202,203],13.41053,52.52437,{"lat":203,"lon":202},[206],{"name":207,"role":51,"phone":16,"phoneExt":16,"email":53},"Charite",{"facility":209,"status":57,"city":210,"state":211,"zip":212,"country":213,"countryCode":214,"cosmosGeoPoint":215,"geoPoint":219,"contacts":16},"Addenbrooke's Hospital","Cambridge","Cambridgeshire","CB2 0QQ","United Kingdom","UK",{"type":64,"coordinates":216},[217,218],0.11667,52.2,{"lat":218,"lon":217},{"facility":221,"status":57,"city":222,"state":223,"zip":224,"country":213,"countryCode":214,"cosmosGeoPoint":225,"geoPoint":229,"contacts":16},"Barts Health NHS Trust","London","Greater London","E1 1RD",{"type":64,"coordinates":226},[227,228],-0.12574,51.50853,{"lat":228,"lon":227},{"facility":231,"status":57,"city":232,"state":233,"zip":234,"country":213,"countryCode":214,"cosmosGeoPoint":235,"geoPoint":239,"contacts":16},"Manchester Royal Infirmary","Manchester","Greater Manchester","M13 9WL",{"type":64,"coordinates":236},[237,238],-2.23743,53.48095,{"lat":238,"lon":237},{"facility":241,"status":57,"city":242,"state":243,"zip":244,"country":213,"countryCode":214,"cosmosGeoPoint":245,"geoPoint":249,"contacts":16},"Cardiff & Vale University HB","Cardiff","South Glamorgan","CF14 4XU",{"type":64,"coordinates":246},[247,248],-3.18,51.48,{"lat":248,"lon":247},{"facility":251,"status":57,"city":252,"state":253,"zip":254,"country":213,"countryCode":214,"cosmosGeoPoint":255,"geoPoint":259,"contacts":16},"Frimley Park Hospital","Frimley","Surrey","GU16 7UJ",{"type":64,"coordinates":256},[257,258],-0.74544,51.31667,{"lat":258,"lon":257},{"facility":261,"status":57,"city":262,"state":263,"zip":264,"country":213,"countryCode":214,"cosmosGeoPoint":265,"geoPoint":269,"contacts":16},"Birmingham Heartlands Hospital","Birmingham","West Midlands","B 9 5SS",{"type":64,"coordinates":266},[267,268],-1.89983,52.48142,{"lat":268,"lon":267},{"facility":271,"status":57,"city":272,"state":273,"zip":274,"country":213,"countryCode":214,"cosmosGeoPoint":275,"geoPoint":279,"contacts":16},"Leeds Teaching Hospitals NHS Trust","Leeds","West Yorkshire","LS9 7TF",{"type":64,"coordinates":276},[277,278],-1.54785,53.79648,{"lat":278,"lon":277},{"type":281,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100593041",false,"NCT07001280","A Study Investigating the Effectiveness and Safety of Garadacimab for Treating Patients With Hereditary Angioedema (HAE)","Garadacimab Real-world Treatment Outcomes of Effectiveness, Safety, and Quality-of-Life in Patients With HAE (GREAT Study)","GREAT","Inclusion Criteria:\n\n* 1\\. Participants aged greater than or equal to (\\>=) 12 years at enrollment.\n* 2\\. Participants with clinical and\u002For laboratory confirmed diagnosis of HAE.\n* 3\\. Participants newly initiating garadacimab, as prescribed according to the decision of the treating physician per routine clinical practice and in accordance with the indication per the approved local label, independent of and prior to enrollment in the study.\n* 4\\. Willing and able to provide written informed consent and\u002For assent by parent or legal guardian for children less than (\\\u003C) 18 years of age (or legal age of consent in the respective countries).\n* 5\\. Ability to use an electronic device such as a smartphone or a computer for data collection in the study.\n\nExclusion Criteria:\n\n* 1\\. Participants with a concomitant diagnosis of another form of angioedema such as idiopathic or acquired angioedema, recurrent angioedema associated with urticaria (histaminergic angioedema).\n* 2\\. Participants participating in any ongoing interventional clinical study, including interventional studies with garadacimab. Participants in this study who later chose to enroll in any interventional clinical study (including garadacimab) will be discontinued from this study.","ALL","12 Years",{"count":292,"type":293},200,"ESTIMATED","OBSERVATIONAL","This is a multinational, multicenter, prospective, observational cohort study of patients with HAE in the real-world setting. The study will include patients newly initiating garadacimab in routine clinical practice. Each participant will be followed for 48 months after index date (date of the first administration of garadacimab).\n\nPatient data will be collected from the HAE eDiary, patient medical records (MRs) and\u002For during a routine clinical visit and will be entered into the electronic case report form (eCRF) via an electronic data capture (EDC) system. Data pertaining to HAE attacks, prior HAE treatments, retrospective focused safety data collection, and healthcare resource utilization (HCRU) over a look-back period of 12 months prior to the enrollment will be extracted from the MR, and patients will also record retrospective HAE attack related data over a look-back period of 3 months prior to enrollment in the HAE eDiary.\n\nThe primary aim of this study is to investigate the real-world effectiveness of garadacimab as measured by HAE attack rate before and after garadacimab initiation in patients with HAE over 24 months of follow-up. The study will aim to complement the data available from the clinical development program on the efficacy, safety, and health-related quality-of-life (HRQoL) in patients with HAE taking garadacimab.",[297],"Hereditary Angioedemas",[299,300,301,302],"Angioedema","Genetic disorder","Long term prophylaxis","Health-related quality of life","2026-06-02",{"date":305,"type":306},"2026-06-03","ACTUAL",{"date":308,"type":306},"2025-07-21",{"date":310,"type":293},"2030-08-31",{"name":5,"class":6},22]