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Patients will be followed for 12 months on reduced dosing.",[12],{"label":20,"type":6,"description":21,"interventionNames":22},"No intervention continuation - open label","Patients with emicizumab concentration of 25-39 μg\u002FmL will continue on their current dose regimen. Patients will be followed for 12 months on current dosing.",[13],{"label":24,"type":6,"description":25,"interventionNames":26},"No intervention adjusted - open label","Patients with emicizumab plasma concentration \\\u003C 25 μg\u002FmL will be adjusted in dosing regimen according to local protocol. Patients will be followed for selective safety data only.",[14],[28,34,39],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Emicizumab - PK-guided dose reduction","PK-guided dose reduction emicizumab targeted at a Ctrough of 30μg\u002FmL.",[9,16],[33],"Hemlibra",{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Emicizumab - Dosis continuation group","Continue on their current dose regimen",[9,20],[33],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Emicizumab - Dose adjustment group","Adjusted in dosing regimen according to local protocol",[9,24],[33],[45],{"name":46,"affiliation":5,"role":47},"Study Officials Fischer, Dr, MD","PRINCIPAL_INVESTIGATOR",[49,55],{"name":50,"role":51,"phone":52,"phoneExt":53,"email":54},"Kathelijn Fischer, Dr, MD.","CONTACT","+318 875 584 50",null,"k.fischer@umcutrecht.nl",{"name":56,"role":51,"phone":57,"phoneExt":53,"email":58},"Konrad VD van der Zwet, 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MD","+31887558450","K.Fischer@umcutrecht.nl",{"name":188,"role":51,"phone":57,"phoneExt":53,"email":189},"Konrad van der Zwet, MD","dosemi@umcutrecht.nl",{"name":184,"role":47,"phone":53,"phoneExt":53,"email":53},{"name":188,"role":80,"phone":53,"phoneExt":53,"email":53},{"name":193,"role":80,"phone":53,"phoneExt":53,"email":53},"Lize F.D. van Vulpen, Dr, MD",{"name":195,"role":80,"phone":53,"phoneExt":53,"email":53},"Roger E.G. Schutgens, Prof, MD",{"name":197,"role":80,"phone":53,"phoneExt":53,"email":53},"Paul van der Valk, MD",{"name":199,"role":80,"phone":53,"phoneExt":53,"email":53},"Karin P.M. van Galen, Dr, MD",{"name":201,"role":80,"phone":53,"phoneExt":53,"email":53},"Nanda Uitslager, Msc",{"type":203,"investigatorFullName":204,"investigatorTitle":205,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"SPONSOR_INVESTIGATOR","Kathelijn Fischer","Principal Investigator",[207,209,210,212,213,214,215,216],{"name":208,"class":6},"Erasmus Medical Center",{"name":97,"class":6},{"name":211,"class":6},"Leiden University Medical Center",{"name":61,"class":6},{"name":82,"class":6},{"name":160,"class":6},{"name":145,"class":6},{"name":217,"class":218},"Dutch Society of Haemophilia Patients","UNKNOWN","100540729","phase-4-pharmacokinetic-guided-dosing-of-emicizumab-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":230,"type":231},95,"ESTIMATED","INTERVENTIONAL",[234],"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.",[237,238,239,240,241,242],"Hemophilia A With Inhibitor","Hemophilia A Without Inhibitor","Hemophilia A, Severe","Adolescent","Child","Adult",[244,245,246,247,248],"Emicizumab","Hemophilia A","Monoclonal antibodies","PK-guided dosing","Hemorrhage","2024-03-12",{"date":251,"type":252},"2024-03-20","ACTUAL",{"date":254,"type":252},"2022-09-08",{"date":256,"type":231},"2026-08",{"name":204,"class":6},8]