Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study

Prior treatment

• Present or past FVIII inhibitor (≥0.6 Bethesda units \[BU\]/mL) according to medical history
• 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

• Current participation in another interventional clinical trial

• Severe haemophilia A (FVIII activity \[FVIII:C\] \<1%) according to medical history
• Male patients at least 12 years of age
• Previous treatment with any FVIII product(s) for at least 150 exposure days
• On regular prophylaxis with emicizumab for at least 1 month prior to a scheduled major elective surgery requiring FVIII treatment
• Freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations