Tests Nuwiq in people with severe haemophilia A having major surgery
Tests Nuwiq to prevent bleeding in people with haemophilia A undergoing surgery.
Plain-language title generated from the registry record
Registry title: Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study
Key facts
- Where
- Madrid and Seville, SpainSee the 2 sites
- Phase
- Phase 4
Where in Spain
- Hospital Universitario La PazMadrid, SpainTaking people
- Hospital Universitario Virgen del RocioSeville, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Octapharma
- Trial code
- NCT05935358
- Record updated
- 12 May 2026
- Original description
Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxisRead full original descriptionShow less
Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study (NuPOWER)
Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis
Inclusion: 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: 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; Coagulation disorder other than haemophilia A; 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); Current participation in another interventional clinical trial.