Clinical Research Directory

Inclusion Criteria: * 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 Exclusion Criteria: * Coagulation disorder other than haemophilia A * Present or past FVIII inhibitor (≥0.6 Bethesda units \[BU\]/mL) according to medical history * 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) * Already had surgery in this study * Current participation in another interventional clinical trial * Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit