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For previously untreated patients (PUPs), who are typically young children, and for minimally treated patients (MTPs), who have been exposed to only minimal FVIII dosages, there is a general interest to increase the body of data on treatment effectiveness and safety, particularly related to inhibitor development. Also, specifically for PUPs, treatment algorithms are not standardized, e.g. with respect to utilisation, dosage, frequency or optimal start age of FVIII prophylaxis. Real world evidence derived from a non-interventional study (NIS) can describe product utilisation and demonstrate value over a product's life cycle and facilitate benefit-risk assessments. The purpose of this study is thus to evaluate product utilisation, effectiveness and safety, including inhibitor development information, in severe haemophilia A PUPs and MTPs, who have been prescribed Octapharma's FVIII concentrates.","A total of 200 patients, either previously untreated patients (PUPs) or minimally treated patients (MTPs), are planned to be documented in the study",[30,33,36],{"label":31,"type":23,"description":32,"interventionNames":23},"Nuwiq","All patients receiving Nuwiq (recombinant FVIII)",{"label":34,"type":23,"description":35,"interventionNames":23},"Octanate","All patients receiving Octanate (plasma derived FVIII)",{"label":37,"type":23,"description":38,"interventionNames":23},"Wilate","All patients receiving Wilate (plasma derived FVIII\u002Fvon Willebrand factor \\[VWF\\])",[40],{"name":41,"affiliation":5,"role":42},"Sigurd Knaub, PhD","STUDY_DIRECTOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":23,"email":48},"Cristina Solomon, MD","CONTACT","+41 79 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3N27","Hamilton","Ontario","1800NOCLOTS","Canada","CA",{"type":59,"coordinates":189},[190,191],-79.84963,43.25011,{"lat":191,"lon":190},{"facility":194,"status":195,"city":196,"state":23,"zip":197,"country":186,"countryCode":187,"cosmosGeoPoint":198,"geoPoint":202,"contacts":23},"Department of Hematology Research Research Transition Facility","COMPLETED","Edmonton","T6G 2V2",{"type":59,"coordinates":199},[200,201],-113.46871,53.55014,{"lat":201,"lon":200},{"facility":204,"status":52,"city":205,"state":23,"zip":23,"country":206,"countryCode":207,"cosmosGeoPoint":208,"geoPoint":212,"contacts":23},"University Hospital Centre Zagreb","Zagreb","Croatia","HR",{"type":59,"coordinates":209},[210,211],15.97798,45.81444,{"lat":211,"lon":210},{"facility":214,"status":88,"city":215,"state":23,"zip":216,"country":217,"countryCode":218,"cosmosGeoPoint":219,"geoPoint":223,"contacts":23},"Tallinn Childrenś Hospital Clinic of Paediatric Department of Haematology and 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l'Hemophilie","Nantes","44093",{"type":59,"coordinates":277},[278,279],-1.55336,47.21725,{"lat":279,"lon":278},[282],{"name":283,"role":46,"phone":23,"phoneExt":23,"email":284},"Marc Fouassier","marc.fouassier@chu-nantes.fr",{"facility":286,"status":52,"city":287,"state":23,"zip":23,"country":227,"countryCode":228,"cosmosGeoPoint":288,"geoPoint":292,"contacts":23},"Hôspital Necker Enfants Malades","Paris",{"type":59,"coordinates":289},[290,291],2.3488,48.85341,{"lat":291,"lon":290},{"facility":294,"status":52,"city":295,"state":23,"zip":296,"country":227,"countryCode":228,"cosmosGeoPoint":297,"geoPoint":301,"contacts":302},"CHRU Hopital Nord, Secretariat de pediatre, bat E niv +3","Saint-Priest-en-Jarez","42270",{"type":59,"coordinates":298},[299,300],4.37678,45.4739,{"lat":300,"lon":299},[303],{"name":304,"role":46,"phone":23,"phoneExt":23,"email":305},"Claire 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GmbH","Duisburg","47051",{"type":59,"coordinates":335},[336,337],6.76516,51.43247,{"lat":337,"lon":336},[340],{"name":341,"role":46,"phone":23,"phoneExt":23,"email":342},"Susan Halimeh","susan.halimeh@gzrr.de",{"facility":344,"status":66,"city":345,"state":23,"zip":23,"country":310,"countryCode":311,"cosmosGeoPoint":346,"geoPoint":350,"contacts":23},"University Hospital Essen","Essen",{"type":59,"coordinates":347},[348,349],7.01228,51.45657,{"lat":349,"lon":348},{"facility":352,"status":66,"city":353,"state":23,"zip":23,"country":310,"countryCode":311,"cosmosGeoPoint":354,"geoPoint":358,"contacts":23},"HZRM GmbH","Frankfurt",{"type":59,"coordinates":355},[356,357],10.53333,49.68333,{"lat":357,"lon":356},{"facility":360,"status":52,"city":361,"state":23,"zip":362,"country":363,"countryCode":364,"cosmosGeoPoint":365,"geoPoint":369,"contacts":370},"Heim Pál National Pediatric Institute Department of Oncology and Hematology","Budapest","1089","Hungary","HU",{"type":59,"coordinates":366},[367,368],19.04045,47.49835,{"lat":368,"lon":367},[371],{"name":372,"role":373,"phone":23,"phoneExt":23,"email":23},"Marianna Zombori","PRINCIPAL_INVESTIGATOR",{"facility":375,"status":52,"city":376,"state":23,"zip":377,"country":363,"countryCode":364,"cosmosGeoPoint":378,"geoPoint":382,"contacts":383},"University of Debrecen Department of Pediatrics","Debrecen","4032",{"type":59,"coordinates":379},[380,381],21.62444,47.53167,{"lat":381,"lon":380},[384],{"name":385,"role":373,"phone":23,"phoneExt":23,"email":23},"Istvan Szegedi",{"facility":387,"status":52,"city":388,"state":23,"zip":23,"country":389,"countryCode":390,"cosmosGeoPoint":391,"geoPoint":395,"contacts":23},"Ospedale Pediatrico \"Giovani 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Riferimento Regionale per la Prevenzione, Diagnosi e Cura delle Malattie Rare della Coagulazione nel Bambino e neel'Adulto. U.O.C Ematologia con trapianto di Midollo Osseo","Catania","95123",{"type":59,"coordinates":423},[424,425],15.07041,37.49223,{"lat":425,"lon":424},{"facility":428,"status":52,"city":429,"state":23,"zip":430,"country":389,"countryCode":390,"cosmosGeoPoint":431,"geoPoint":435,"contacts":436},"Azienda Ospedaliero Universitaria Careggi","Florence","50134",{"type":59,"coordinates":432},[433,434],11.24626,43.77925,{"lat":434,"lon":433},[437],{"name":438,"role":46,"phone":23,"phoneExt":23,"email":439},"Giancarlo Castaman","giancarlo.castaman@unifi.it",{"facility":441,"status":52,"city":442,"state":23,"zip":443,"country":389,"countryCode":390,"cosmosGeoPoint":444,"geoPoint":448,"contacts":449},"Ospedale Maggiore Policlinico","Milan","920122",{"type":59,"coordinates":445},[446,447],9.18951,45.46427,{"lat":447,"lon":446},[450],{"name":451,"role":46,"phone":23,"phoneExt":23,"email":452},"Elena Santangostino","elena.santagostino@unimi.it",{"facility":454,"status":52,"city":442,"state":23,"zip":23,"country":389,"countryCode":390,"cosmosGeoPoint":455,"geoPoint":457,"contacts":23},"Center for Thrombosis and Hemorrhagic Diseases, IRCCS Humanitas Research Hospital",{"type":59,"coordinates":456},[446,447],{"lat":447,"lon":446},{"facility":459,"status":88,"city":460,"state":23,"zip":23,"country":389,"countryCode":390,"cosmosGeoPoint":461,"geoPoint":465,"contacts":23},"Centro Emofilia - AUO di Padova","Padova",{"type":59,"coordinates":462},[463,464],11.14261,44.38225,{"lat":464,"lon":463},{"facility":467,"status":52,"city":468,"state":23,"zip":469,"country":389,"countryCode":390,"cosmosGeoPoint":470,"geoPoint":474,"contacts":475},"Policlinico Umberto I","Rome","00161",{"type":59,"coordinates":471},[472,473],12.51133,41.89193,{"lat":473,"lon":472},[476,479],{"name":477,"role":46,"phone":23,"phoneExt":23,"email":478},"Antonio Chistolini","antonio.chistolini@uniroma1.it",{"name":23,"role":46,"phone":23,"phoneExt":23,"email":480},"chistolini@bce.uniroma1.it",{"facility":482,"status":52,"city":483,"state":23,"zip":23,"country":389,"countryCode":390,"cosmosGeoPoint":484,"geoPoint":488,"contacts":23},"C.tro Emofilia A.O. Città della salute e della scienza di Torino, Ospedale Regina Margherita","Torino",{"type":59,"coordinates":485},[486,487],11.99138,44.88856,{"lat":487,"lon":486},{"facility":490,"status":88,"city":491,"state":23,"zip":492,"country":389,"countryCode":390,"cosmosGeoPoint":493,"geoPoint":497,"contacts":23},"Ospedale Regina Margherita","Turin","10126",{"type":59,"coordinates":494},[495,496],7.68682,45.07049,{"lat":496,"lon":495},{"facility":499,"status":52,"city":500,"state":23,"zip":501,"country":502,"countryCode":503,"cosmosGeoPoint":504,"geoPoint":508,"contacts":509},"Children's Hospital Affiliate of Vilnius Universtity Hospital Santaros Klinikos","Vilnius","LT-08406","Lithuania","LT",{"type":59,"coordinates":505},[506,507],25.2798,54.68916,{"lat":507,"lon":506},[510,513],{"name":511,"role":46,"phone":23,"phoneExt":23,"email":512},"Sonata Saulyte Trakymiene","sonata.trakymiene@vuvl.lt",{"name":23,"role":46,"phone":23,"phoneExt":23,"email":514},"sonatrak@gmail.com",{"facility":516,"status":52,"city":517,"state":23,"zip":23,"country":518,"countryCode":519,"cosmosGeoPoint":520,"geoPoint":524,"contacts":23},"Hospital General de Occidente, Unidad de Hemato-Oncologia Pediatric, Av. Zoquipan 1050, Col Seattle, , Col Seattle","Jalisco","Mexico","MX",{"type":59,"coordinates":521},[522,523],-91.97499,16.43033,{"lat":523,"lon":522},{"facility":526,"status":77,"city":527,"state":23,"zip":23,"country":518,"countryCode":519,"cosmosGeoPoint":528,"geoPoint":532,"contacts":23},"Hospital Infantil de Morelia Eva Sámano de López Mateos","Morelia",{"type":59,"coordinates":529},[530,531],-101.18443,19.70078,{"lat":531,"lon":530},{"facility":534,"status":77,"city":535,"state":23,"zip":23,"country":518,"countryCode":519,"cosmosGeoPoint":536,"geoPoint":540,"contacts":23},"Hospital Universitario Dr. José Eleuterio Gonzalez S\u002FN","Nuevo León",{"type":59,"coordinates":537},[538,539],-115.18896,32.4095,{"lat":539,"lon":538},{"facility":542,"status":77,"city":535,"state":23,"zip":23,"country":518,"countryCode":519,"cosmosGeoPoint":543,"geoPoint":545,"contacts":23},"SMO and Scientific Services S.A.P.P de C.V",{"type":59,"coordinates":544},[538,539],{"lat":539,"lon":538},{"facility":547,"status":88,"city":548,"state":23,"zip":549,"country":550,"countryCode":551,"cosmosGeoPoint":552,"geoPoint":556,"contacts":23},"Moscow State Government-financed Public Healthcare Institution \"Morozovskaya Children Clinical Hospital of Moscow Healthcare Department\"","Moscow","119049","Russia","RU",{"type":59,"coordinates":553},[554,555],37.61781,55.75204,{"lat":555,"lon":554},{"facility":558,"status":88,"city":559,"state":23,"zip":560,"country":550,"countryCode":551,"cosmosGeoPoint":561,"geoPoint":565,"contacts":23},"Saint-Petersburg State Budget Healthcare Institution \"City Out-patient Clinical # 37\"","Saint Petersburg","191186",{"type":59,"coordinates":562},[563,564],30.31413,59.93863,{"lat":564,"lon":563},{"facility":567,"status":52,"city":568,"state":23,"zip":569,"country":570,"countryCode":571,"cosmosGeoPoint":572,"geoPoint":576,"contacts":577},"Hospital General Universitario de Alicante Hematología y Hemoterapia","Alicante","03010","Spain","ES",{"type":59,"coordinates":573},[574,575],-0.48149,38.34517,{"lat":575,"lon":574},[578],{"name":579,"role":46,"phone":23,"phoneExt":23,"email":580},"Pascual Marco Vera","marco.pas@gva.es",{"facility":582,"status":52,"city":583,"state":23,"zip":584,"country":570,"countryCode":571,"cosmosGeoPoint":585,"geoPoint":589,"contacts":590},"Hospital Universitari Vall D'Hebrón, Unitat d'Hemofilia","Barcelona","02035",{"type":59,"coordinates":586},[587,588],2.15899,41.38879,{"lat":588,"lon":587},[591],{"name":592,"role":46,"phone":23,"phoneExt":23,"email":593},"Olga Benitez Hidalgo","25600173t@vhebron.net",{"facility":595,"status":77,"city":596,"state":23,"zip":23,"country":570,"countryCode":571,"cosmosGeoPoint":597,"geoPoint":601,"contacts":23},"HRU Malaga","Málaga",{"type":59,"coordinates":598},[599,600],-4.42034,36.72016,{"lat":600,"lon":599},{"facility":603,"status":66,"city":604,"state":23,"zip":23,"country":570,"countryCode":571,"cosmosGeoPoint":605,"geoPoint":609,"contacts":23},"Universitary Hospital Son Espases (Hematology Service)","Palma de Mallorca",{"type":59,"coordinates":606},[607,608],2.65024,39.56939,{"lat":608,"lon":607},{"facility":611,"status":66,"city":612,"state":23,"zip":23,"country":570,"countryCode":571,"cosmosGeoPoint":613,"geoPoint":617,"contacts":23},"Hospital Universitario y Politécnico La Fe","Valencia",{"type":59,"coordinates":614},[615,616],-0.37966,39.47391,{"lat":616,"lon":615},{"facility":619,"status":88,"city":620,"state":23,"zip":23,"country":621,"countryCode":23,"cosmosGeoPoint":622,"geoPoint":626,"contacts":23},"Istanbul University Faculty of Medicine","Fatih","Turkey (Türkiye)",{"type":59,"coordinates":623},[624,625],34.58903,37.05738,{"lat":625,"lon":624},{"facility":628,"status":52,"city":629,"state":630,"zip":631,"country":632,"countryCode":633,"cosmosGeoPoint":634,"geoPoint":638,"contacts":639},"John Radcliffe Hospital, Oxford University Hospitals, NHS Foundation Trust","Headington","Oxford","OX3 9DU","United Kingdom","UK",{"type":59,"coordinates":635},[636,637],-1.21974,51.75737,{"lat":637,"lon":636},[640,643],{"name":641,"role":46,"phone":23,"phoneExt":23,"email":642},"Neha Bhatnagar","Neha.Bhatnagar@ouh.nhs.uk",{"name":644,"role":46,"phone":23,"phoneExt":23,"email":645},"Georgina Hall","georgina.hall@peadiatrics.ox.ac.uk",{"facility":647,"status":88,"city":648,"state":23,"zip":649,"country":632,"countryCode":633,"cosmosGeoPoint":650,"geoPoint":654,"contacts":23},"Birmingham Children's Hospital NHS Foundation Trust","Birmingham","B46NH",{"type":59,"coordinates":651},[652,653],-1.89983,52.48142,{"lat":653,"lon":652},{"facility":656,"status":52,"city":657,"state":23,"zip":658,"country":632,"countryCode":633,"cosmosGeoPoint":659,"geoPoint":663,"contacts":664},"Great Ormond Street Hospital for Children NHS Trust, Haemophilia Centre","London","WC1N 3JH",{"type":59,"coordinates":660},[661,662],-0.12574,51.50853,{"lat":662,"lon":661},[665],{"name":666,"role":46,"phone":23,"phoneExt":23,"email":667},"Raina Liesner","Ri.Liesner@gosh.nhs.uk",{"facility":669,"status":52,"city":670,"state":23,"zip":671,"country":632,"countryCode":633,"cosmosGeoPoint":672,"geoPoint":676,"contacts":677},"Newcastle Haemophilia Comprehensive Care Centre, Royal Victoria Infirmary","Newcastle upon Tyne","NE1 4LP",{"type":59,"coordinates":673},[674,675],-1.61396,54.97328,{"lat":675,"lon":674},[678],{"name":679,"role":46,"phone":23,"phoneExt":23,"email":680},"Tina Biss","Tina.Biss@nuth.nhs.uk",{"type":682,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100339167","efficacy-safety--utilisation-of-nuwiq-octanate-and-wilate-in-previously-untreated--minimally-treated-haemophilia-a-patients-100339167",false,"NCT03695978","Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients","Practical Utilisation of Octapharma FVIII Concentrates in Previously Untreated & Minimally Treated Haemophilia A Patients Entering Routine Clinical Treatment With Nuwiq, Octanate or Wilate - Efficacy & Safety Observational Study-Protect-NOW","Protect-NOW","Inclusion Criteria:\n\n* Male and female patients of any age and ethnicity\n* Severe haemophilia A (FVIII:C\\\u003C1%)\n* Decision to prescribe Octapharma's FVIII concentrate before enrollment into the study\n* Either\n* No previous treatment with FVIII concentrates or other blood products containing FVIII (PUPs) OR\n* Less than 5 Exposure Days (EDs) to FVIII concentrates or other blood products containing FVIII (MTPs), if\n* data are available on all previous treatment, AND\n* they did not develop an inhibitor at any time point, OR\n* they developed an inhibitor during treatment with an Octapharma FVIII concentrate AND continue treatment with THIS Octapharma FVIII concentrate (in the presence or absence of emicizumab).\n* Voluntarily given, fully informed written and signed consent obtained before any study-related data documentation is conducted (obtained from the patient's parent\u002Flegal guardian)\n\nExclusion Criteria:\n\n* Diagnosis with a coagulation disorder other than haemophilia A\n* Concomitant treatment with any systemic immunosuppressive drug\n* Participation in an interventional clinical trial during the time period evaluated\n* Participation in another non-interventional study of Octapharma","ALL",{"count":693,"type":694},200,"ESTIMATED","OBSERVATIONAL","International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally treated severe haemophilia A patients in routine clinical practice.",[698],"Haemophilia A","2026-05-29",{"date":701,"type":702},"2026-06-02","ACTUAL",{"date":704,"type":702},"2018-02-13",{"date":706,"type":694},"2030-06",{"name":5,"class":6},59]