[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540729":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":44,"centralContacts":48,"locations":59,"responsibleParty":201,"collaborators":205,"id":218,"slug":53,"hasResults":219,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":219,"sex":225,"minAge":226,"maxAge":53,"enrollmentInfo":227,"targetDuration":53,"studyType":230,"phases":231,"briefSummary":233,"conditions":234,"keywords":241,"overallStatus":62,"whyStopped":53,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":256},{"fullName":5,"class":6},"UMC Utrecht","OTHER",[8,15,19,23],{"label":9,"type":6,"description":10,"interventionNames":11},"Conventional dosing - open label","Patients will be followed 6 months retrospectively and 6 months prospectively on conventional dosing.",[12,13,14],"Other: Emicizumab - PK-guided dose reduction","Other: Emicizumab - Dosis continuation group","Other: Emicizumab - Dose adjustment group",{"label":16,"type":6,"description":17,"interventionNames":18},"PK-guided dosing - open label","Patients with emicizumab concentration of ≥ 40 μg\u002FmL will receive individualized PK-guided dose reduction of emicizumab targeted at a Ctrough of 30μg\u002FmL. 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, MD","+31650124691","k.vanderzwet@umcutrecht.nl",[60,80,95,111,127,143,158,173],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Radboud University Medical Center","RECRUITING","Nijmegen","Gelderland","6525 GA","Netherlands",{"type":68,"coordinates":69},"Point",[70,71],5.85278,51.8425,{"lat":71,"lon":70},[74,78],{"name":75,"role":51,"phone":76,"phoneExt":53,"email":77},"Saskia Schols, Dr, MD","+310 24 361 8823","Saskia.Schols@radboudumc.nl",{"name":75,"role":79,"phone":53,"phoneExt":53,"email":53},"SUB_INVESTIGATOR",{"facility":81,"status":62,"city":82,"state":83,"zip":53,"country":66,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Maastricht University Medical Center","Maastricht","Limburg",{"type":68,"coordinates":85},[86,87],5.68889,50.84833,{"lat":87,"lon":86},[90,94],{"name":91,"role":51,"phone":92,"phoneExt":53,"email":93},"Floor Moenen, Dr, 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1850","p.l.den_exter@lumc.nl",{"name":123,"role":79,"phone":53,"phoneExt":53,"email":53},{"facility":128,"status":62,"city":129,"state":114,"zip":130,"country":66,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Erasmus University Medical Center","Rotterdam","3000CA",{"type":68,"coordinates":132},[133,134],4.47917,51.9225,{"lat":134,"lon":133},[137,141],{"name":138,"role":51,"phone":139,"phoneExt":53,"email":140},"Marjon Cnossen, Dr., MD","+31107040113","m.cnossen@erasmusmc.nl",{"name":142,"role":79,"phone":53,"phoneExt":53,"email":53},"Marjon Cnossen, Dr. MD",{"facility":144,"status":62,"city":145,"state":114,"zip":146,"country":66,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"HagaZiekenhuis","The Hague","2545 CH",{"type":68,"coordinates":148},[149,150],4.29861,52.07667,{"lat":150,"lon":149},[153,157],{"name":154,"role":51,"phone":155,"phoneExt":53,"email":156},"Paula Ypma, 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MD","+31887558450","K.Fischer@umcutrecht.nl",{"name":187,"role":51,"phone":57,"phoneExt":53,"email":188},"Konrad van der Zwet, MD","dosemi@umcutrecht.nl",{"name":183,"role":47,"phone":53,"phoneExt":53,"email":53},{"name":187,"role":79,"phone":53,"phoneExt":53,"email":53},{"name":192,"role":79,"phone":53,"phoneExt":53,"email":53},"Lize F.D. van Vulpen, Dr, MD",{"name":194,"role":79,"phone":53,"phoneExt":53,"email":53},"Roger E.G. Schutgens, Prof, MD",{"name":196,"role":79,"phone":53,"phoneExt":53,"email":53},"Paul van der Valk, MD",{"name":198,"role":79,"phone":53,"phoneExt":53,"email":53},"Karin P.M. van Galen, Dr, MD",{"name":200,"role":79,"phone":53,"phoneExt":53,"email":53},"Nanda Uitslager, Msc",{"type":202,"investigatorFullName":203,"investigatorTitle":204,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"SPONSOR_INVESTIGATOR","Kathelijn Fischer","Principal Investigator",[206,208,209,211,212,213,214,215],{"name":207,"class":6},"Erasmus Medical Center",{"name":96,"class":6},{"name":210,"class":6},"Leiden University Medical Center",{"name":61,"class":6},{"name":81,"class":6},{"name":159,"class":6},{"name":144,"class":6},{"name":216,"class":217},"Dutch Society of Haemophilia Patients","UNKNOWN","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":228,"type":229},95,"ESTIMATED","INTERVENTIONAL",[232],"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.",[235,236,237,238,239,240],"Hemophilia A With Inhibitor","Hemophilia A Without Inhibitor","Hemophilia A, Severe","Adolescent","Child","Adult",[242,243,244,245,246],"Emicizumab","Hemophilia A","Monoclonal antibodies","PK-guided dosing","Hemorrhage","2024-03-12",{"date":249,"type":250},"2024-03-20","ACTUAL",{"date":252,"type":250},"2022-09-08",{"date":254,"type":229},"2026-08",{"name":203,"class":6},8]