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Biss","Tina.Biss@nuth.nhs.uk",{"type":661,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"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":672,"type":673},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.",[677],"Haemophilia A","2026-05-29",{"date":680,"type":681},"2026-06-02","ACTUAL",{"date":683,"type":681},"2018-02-13",{"date":685,"type":673},"2030-06",{"name":5,"class":6},59]