[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100120673":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":11,"locations":32,"responsibleParty":101,"collaborators":11,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":11,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":11,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":11,"overallStatus":123,"whyStopped":11,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Novo Nordisk A\u002FS","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Advate®\u002Fturoctocog alfa","EXPERIMENTAL",null,[13,14],"Drug: Advate®","Drug: turoctocog alfa",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"DRUG","Advate®","Subjects will receive Advate® at a dose of 50 IU\u002Fkg body weight in the first session",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"turoctocog alfa","After a washout period of 4 days, subjects will subsequently receive turoctocog alfa (recombinant factor VIII (N8)) at a dose of 50 IU\u002Fkg body weight in the second session",[9],[26,27],"recombinant FVIII","N8",[29],{"name":30,"affiliation":5,"role":31},"Global Clinical Registry (GCR, 1452)","STUDY_DIRECTOR",[33,45,53,63,73,81,91],{"facility":34,"status":11,"city":35,"state":11,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":11},"Novo Nordisk Investigational Site","Berlin","10249","Germany","DE",{"type":40,"coordinates":41},"Point",[42,43],13.41053,52.52437,{"lat":43,"lon":42},{"facility":34,"status":11,"city":46,"state":11,"zip":47,"country":37,"countryCode":38,"cosmosGeoPoint":48,"geoPoint":52,"contacts":11},"Hanover","30625",{"type":40,"coordinates":49},[50,51],9.73322,52.37052,{"lat":51,"lon":50},{"facility":34,"status":11,"city":54,"state":11,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":62,"contacts":11},"Tel Litwinsky","52621","Israel","IL",{"type":40,"coordinates":59},[60,61],34.84588,32.05096,{"lat":61,"lon":60},{"facility":34,"status":11,"city":64,"state":11,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":72,"contacts":11},"Florence","50134","Italy","IT",{"type":40,"coordinates":69},[70,71],11.24626,43.77925,{"lat":71,"lon":70},{"facility":34,"status":11,"city":74,"state":11,"zip":75,"country":66,"countryCode":67,"cosmosGeoPoint":76,"geoPoint":80,"contacts":11},"Milan","20124",{"type":40,"coordinates":77},[78,79],12.59836,42.78235,{"lat":79,"lon":78},{"facility":34,"status":11,"city":82,"state":11,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":90,"contacts":11},"Madrid","28046","Spain","ES",{"type":40,"coordinates":87},[88,89],-3.70256,40.4165,{"lat":89,"lon":88},{"facility":34,"status":11,"city":92,"state":11,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":100,"contacts":11},"Zurich","8091","Switzerland","CH",{"type":40,"coordinates":97},[98,99],8.55,47.36667,{"lat":99,"lon":98},{"type":102,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100120673","phase-1-comparison-of-the-action-of-drugs-in-the-body-and-safety-of-n8-and-advate-in-haemophilia-a-subjects-100120673",false,"NCT00837356","Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects","A Multi-centre, Multi-national Open-label Sequential Trial Comparing Pharmacokinetics and Safety of N8 and Advate® in Subjects With Haemophilia A","Inclusion Criteria:\n\n* Severe haemophilia A (FVIII level less than or equal to 1%)\n* Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products\n* HIV or HCV negative, or if positive the patient is on a stable antiviral regimen at the time of the enrolment in the trial\n\nExclusion Criteria:\n\n* Presence of any bleeding disorder in addition to haemophilia A\n* Inhibitor titre greater than or equal to 0.6 Bethesda Units (BU) at screening and past history of inhibitor\n* Abnormal renal function tests\n* Known hypersensitivity to Advate®","MALE","12 Years","55 Years",{"count":114,"type":115},23,"ACTUAL","INTERVENTIONAL",[118],"PHASE1","This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia A subjects, investigating the action and safety of the drugs.",[121,122],"Congenital Bleeding Disorder","Haemophilia A","COMPLETED","2017-02-09",{"date":126,"type":115},"2017-02-10",{"date":128,"type":11},"2009-03",{"date":130,"type":115},"2009-10",{"name":5,"class":6},7]