[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kathelijn Fischer\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":51},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100540729",false,"NCT06320626","Pharmacokinetic-guided Dosing of Emicizumab","Pharmacokinetic-guided Dosing of Emicizumab in Congenital Haemophilia A Patients - The DosEmi Study","DosEmi","Inclusion Criteria:\n\n* Confirmed diagnosis of congenital haemophilia A, with a baseline endogenous FVIII of \\\u003C6 IU\u002Fml\n* Aged \\> 1 year at inclusion (inclusion of children 1-16 years after favourable interim-analysis see protocol)\n* Receiving conventional dosing of emicizumab (6 mg\u002Fkg\u002F4 weeks with varying intervals) for a duration of at least 12 months prior to inclusion;\n* Having good bleeding control, defined as:\n\ni No spontaneous joint\u002Fmuscle bleeds in the previous 6 months AND ii A maximum of two treated (traumatic) bleeds in the previous 6 months.\n\n* Willing and able to provide written informed consent, either by the subject or its parents\u002Flegal guardian\n* Willing to provide bleeding assessment information\n* Willing to adhere to the medication regimen\n\nExclusion Criteria:\n\n* Acquired haemophilia A","MALE","1 Year",{"count":19,"type":20},95,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","The goal of this multicentre, prospective, open-label, cross-over clinical study is to determine whether individualized PK-guided dosing of emicizumab is non-inferior to conventional dosing of emicizumab in the prevention of bleeding in congenital haemophilia A patients.",[26,27,28,29,30,31],"Hemophilia A With Inhibitor","Hemophilia A Without Inhibitor","Hemophilia A, Severe","Adolescent","Child","Adult",[33,34,35,36,37],"Emicizumab","Hemophilia A","Monoclonal antibodies","PK-guided dosing","Hemorrhage","RECRUITING","2024-03-12",{"date":41,"type":42},"2024-03-20","ACTUAL",{"date":44,"type":42},"2022-09-08",{"date":46,"type":20},"2026-08",{"name":48,"class":49},"Kathelijn Fischer","OTHER",8,""]