Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery - an International, Open-label, Non-controlled Study (NuDIMENSION)
Octapharma
Summary
Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery
Description
Female patients with mild to moderate haemophilia A will often need FVIII concentrates to provide haemostatic cover during major surgery. This prospective, open-label, non-controlled, single-arm, multinational, multicentre study aims to evaluate the overall perioperative haemostatic efficacy of Nuwiq in women/girls over 12 with haemophilia A undergoing major surgery requiring FVIII treatment
Eligibility
- Age range
- 12+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Women/girls with haemophilia A (FVIII:C ≥1-\<40%) according to medical history. Additionally, women/girls 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/or 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) 2. At least 12 years of age 3…
Interventions
- DrugNuwiq
Nuwiq is a purified B-domain-deleted FVIII glycoprotein synthesised by a genetically engineered human embryonic kidney cell line (HEK 293F).
Locations (15)
- UT Health San AntonioSan Antonio, Texas
- Helsinki University Hospital,Coagulation Disorder UnitHelsinki
- Avenue de la RépubliqueChambray-lès-Tours
- CHU de Nantes Hôtel-DieuNantes
- Universitätsklinikum Bonn,Institut für Experimentelle Haematologie und TransfusionsmedizinBonn
- Gerinnungszentrum Rhein-RuhrDuisburg