Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery

Prior treatment

• Present or past FVIII inhibitor (≥0.6 Bethesda units \[BU\]/mL)
• Already had surgery in this study
• Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit

Other illness

• Coagulation disorder other than haemophilia A

Lab values

• Severe liver or kidney disease (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\] levels \>5 times the upper limit of normal; or creatinine \>120 μmol/L)
• Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)

Other

• Pregnancy, except in participants with a planned caesarean section
• Current participation in another interventional clinical trial

• 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)
• At least 12 years of age
• Scheduled to undergo major surgery\* requiring FVIII treatment, including elective and emergency procedures and caesarean section in pregnant women with haemophilia A
• Freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations