[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511218":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":180,"collaborators":19,"id":182,"slug":183,"hasResults":184,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":19,"eligibilityCriteria":188,"healthyVolunteers":184,"sex":189,"minAge":190,"maxAge":19,"enrollmentInfo":191,"targetDuration":19,"studyType":194,"phases":195,"briefSummary":197,"conditions":198,"keywords":19,"overallStatus":34,"whyStopped":19,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":209},{"fullName":5,"class":6},"Octapharma","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Nuwiq","EXPERIMENTAL","All patients receiving Nuwiq (recombinant FVIII). Nuwiq will be administered intravenously in accordance with the relevant prescribing information. Treatment will be repeated as necessary every 8-24 hours until adequate wound healing, then - if required - for at least another 7 days to maintain FVIII plasma levels of 30-60 IU\u002FdL.",[13],"Drug: Nuwiq",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Nuwiq is a purified B-domain-deleted FVIII glycoprotein synthesised by a genetically engineered human embryonic kidney cell line (HEK 293F).",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Johannes Oldenburg","Experimental Haematology and Transfusion Medicine, University Clinic Bonn","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Cristina Solomon","CONTACT","+41795859042","cristina.solomon@octapharma.com",[32,46,56,66,74,78,88,96,104,114,122,132,142,150,160,170],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":19},"UT Health San Antonio","RECRUITING","San Antonio","Texas","78229","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-98.49363,29.42412,{"lat":44,"lon":43},{"facility":47,"status":34,"city":48,"state":19,"zip":19,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":55,"contacts":19},"Helsinki University Hospital,Coagulation Disorder Unit","Helsinki","Finland","FI",{"type":41,"coordinates":52},[53,54],24.93545,60.16952,{"lat":54,"lon":53},{"facility":57,"status":34,"city":58,"state":19,"zip":19,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":65,"contacts":19},"Avenue de la République","Chambray-lès-Tours","France","FR",{"type":41,"coordinates":62},[63,64],0.70286,47.33537,{"lat":64,"lon":63},{"facility":67,"status":34,"city":68,"state":19,"zip":19,"country":59,"countryCode":60,"cosmosGeoPoint":69,"geoPoint":73,"contacts":19},"CHU de Nantes Hôtel-Dieu","Nantes",{"type":41,"coordinates":70},[71,72],-1.55336,47.21725,{"lat":72,"lon":71},{"facility":75,"status":76,"city":77,"state":19,"zip":19,"country":59,"countryCode":60,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"Chu de Strasbourg","NOT_YET_RECRUITING","Stasbourg",{"facility":79,"status":34,"city":80,"state":19,"zip":19,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":87,"contacts":19},"Universitätsklinikum Bonn,Institut für Experimentelle Haematologie und Transfusionsmedizin","Bonn","Germany","DE",{"type":41,"coordinates":84},[85,86],7.09549,50.73438,{"lat":86,"lon":85},{"facility":89,"status":34,"city":90,"state":19,"zip":19,"country":81,"countryCode":82,"cosmosGeoPoint":91,"geoPoint":95,"contacts":19},"Gerinnungszentrum Rhein-Ruhr","Duisburg",{"type":41,"coordinates":92},[93,94],6.76516,51.43247,{"lat":94,"lon":93},{"facility":97,"status":34,"city":98,"state":19,"zip":19,"country":81,"countryCode":82,"cosmosGeoPoint":99,"geoPoint":103,"contacts":19},"Universitätsklinikum Hamburg Eppendorf,II. Medizinische Klinik und Poliklinik","Hamburg",{"type":41,"coordinates":100},[101,102],9.99302,53.55073,{"lat":102,"lon":101},{"facility":105,"status":34,"city":106,"state":19,"zip":19,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":113,"contacts":19},"Aziendo Ospedaliera \"Puglieze Ciaccio\"","Catanzaro","Italy","IT",{"type":41,"coordinates":110},[111,112],16.60086,38.88247,{"lat":112,"lon":111},{"facility":115,"status":34,"city":116,"state":19,"zip":19,"country":107,"countryCode":108,"cosmosGeoPoint":117,"geoPoint":121,"contacts":19},"Policlinico \"P. Giaconne\"","Palermo",{"type":41,"coordinates":118},[119,120],13.3636,38.1166,{"lat":120,"lon":119},{"facility":123,"status":34,"city":124,"state":19,"zip":19,"country":125,"countryCode":126,"cosmosGeoPoint":127,"geoPoint":131,"contacts":19},"Clinical Center for Serbia","Belgrade","Serbia","RS",{"type":41,"coordinates":128},[129,130],20.46513,44.80401,{"lat":130,"lon":129},{"facility":133,"status":34,"city":134,"state":19,"zip":19,"country":135,"countryCode":136,"cosmosGeoPoint":137,"geoPoint":141,"contacts":19},"Hospital Universitario la Paz","Madrid","Spain","ES",{"type":41,"coordinates":138},[139,140],-3.70256,40.4165,{"lat":140,"lon":139},{"facility":143,"status":34,"city":144,"state":19,"zip":19,"country":135,"countryCode":136,"cosmosGeoPoint":145,"geoPoint":149,"contacts":19},"Hospital Universitario Virgen del Rocio","Seville",{"type":41,"coordinates":146},[147,148],-5.97317,37.38283,{"lat":148,"lon":147},{"facility":151,"status":76,"city":152,"state":19,"zip":19,"country":153,"countryCode":154,"cosmosGeoPoint":155,"geoPoint":159,"contacts":19},"Insel Spital Bern","Bern","Switzerland","CH",{"type":41,"coordinates":156},[157,158],7.44744,46.94809,{"lat":158,"lon":157},{"facility":161,"status":34,"city":162,"state":19,"zip":19,"country":163,"countryCode":164,"cosmosGeoPoint":165,"geoPoint":169,"contacts":19},"St. James's University Hospital","Leeds","United Kingdom","UK",{"type":41,"coordinates":166},[167,168],-1.54785,53.79648,{"lat":168,"lon":167},{"facility":171,"status":76,"city":172,"state":19,"zip":19,"country":173,"countryCode":174,"cosmosGeoPoint":175,"geoPoint":179,"contacts":19},"Centro Hospitalario Pereira Rossell","Montevideo","Uruguay","UY",{"type":41,"coordinates":176},[177,178],-56.18816,-34.90328,{"lat":178,"lon":177},{"type":181,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100511218","phase-4-nuwiq-dosing-and-outcomes-in-the-management-of-womengirls-with-haemophilia-a-needing-fviii-treatment-for-surgery-100511218",false,"NCT05936580","Nuwiq Dosing and Outcomes In the ManagEment of Women\u002FGirls With Haemophilia A Needing FVIII Treatment for Surgery","Nuwiq Dosing and Outcomes In the ManagEment of Women\u002FGirls With Haemophilia A Needing FVIII Treatment for Surgery - an International, Open-label, Non-controlled Study (NuDIMENSION)","Inclusion Criteria:\n\n1. Women\u002Fgirls with haemophilia A (FVIII:C ≥1-\\\u003C40%) according to medical history. Additionally, women\u002Fgirls with documented FVIII activity levels between ≥ 40% and 50% may be included if there is a documented history of clinically significant bleeding episodes consistent with haemophilia A; and\u002For either documented prior treatment with FVIII concentrates or a clinical indication that FVIII treatment would have been appropriate (e.g., use of FVIII from a family member, or treatment with alternative haemostatic agents due to access limitations)\n2. At least 12 years of age\n3. Scheduled to undergo major surgery\\* requiring FVIII treatment, including elective and emergency procedures and caesarean section in pregnant women with haemophilia A\n4. Freely given written informed consent of the patient, or parent\u002Flegal representative where applicable, obtained in accordance with local regulations\n\nExclusion Criteria:\n\n1. Coagulation disorder other than haemophilia A\n2. Present or past FVIII inhibitor (≥0.6 Bethesda units \\[BU\\]\u002FmL)\n3. Severe liver or kidney disease (alanine aminotransferase \\[ALT\\] and\u002For aspartate aminotransferase \\[AST\\] levels \\>5 times the upper limit of normal; or creatinine \\>120 μmol\u002FL)\n4. Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)\n5. Pregnancy, except in participants with a planned caesarean section\n6. Already had surgery in this study\n7. Current participation in another interventional clinical trial\n8. Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit","FEMALE","12 Years",{"count":192,"type":193},28,"ESTIMATED","INTERVENTIONAL",[196],"PHASE4","Recombinant factor VIII for the prevention of bleeding in women\u002Fgirls with haemophilia A undergoing major surgery",[199],"Hemophilia A","2026-05-08",{"date":202,"type":203},"2026-05-12","ACTUAL",{"date":205,"type":193},"2026-04",{"date":207,"type":193},"2027-02",{"name":5,"class":6},16]