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)

Prior treatment

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

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 moderate or mild haemophilia A (FVIII activity [FVIII:C] ≥1 - <40%) according to medical history
• At least 12 years of age
• Scheduled to undergo major elective surgery* requiring FVIII treatment, including elective and emergency procedures and caesarean section in pregnant women with haemophilia A Note: - Pregnant participants may be included regardless of current FVIII activity levels, acknowledging physiological increases during pregnancy; Inclusion is permitted if, in the opinion of the Investigator, the participant is expected to require FVIII treatment before and during the immediate postpartum period (for a minimum of 3 days following deliverycaesarean section). Participants undergoing eEmergency surgeries may be included if the Investigator confirms that all protocol requirements are can be met, including timely informed consent (ICF) and adherence to the sampling schedule.
• Freely given written informed consent of the participant, or parent/legal representative where applicable, obtained in accordance with local regulations
• Additionally, women/girls with documented FVIII activity levels between ≥>40% and 50% may be included if the following criteria are met: There is a documented history of clinically significant bleeding episodes consistent with haemophilia A; and/or There is either documented prior treatment with FVIII concentrates or a clear 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);
• Note: Participants with transiently elevated FVIII levels due to physiological or pathological conditions (e.g., inflammation, pregnancy, malignancy) may still be eligible if historical data supports a diagnosis of haemophilia A.