Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis study (NuPOWER)
Key facts
- Where
- Catanzaro, Florence és Rozzano, OlaszországSee the 3 sites
- Phase
- 4. fázis
Where in Olaszország
- Azienda Ospedaliera Pugliese CiaccioCatanzaro, OlaszországNo longer taking part
- Careggi University HospitalFlorence, OlaszországNo longer taking part
- Humanitas Research HospitalRozzano, OlaszországNo longer taking part
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 AG
- Trial code
- EU 2022-502060-21-00
- Record updated
- 2025. szeptember 25.
- Original description
The primary objective of this study is to evaluate the overall perioperative haemostatic efficacy of Nuwiq, in combination with ongoing emicizumab prophylaxis, in patients with severe haemophilia A undergoing major surgery.Read full original descriptionShow less
The primary objective of this study is to evaluate the overall perioperative haemostatic efficacy of Nuwiq, in combination with ongoing emicizumab prophylaxis, in patients with severe haemophilia A undergoing major surgery.
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 3 months prior to a scheduled major elective surgery requiring FVIII treatment; Freely given written informed consent.
Exclusion: Present or past FVIII inhibitor (≥0.6 Bethesda units [BU]/mL) according to medical history; Treatment with any investigational product within 30 days prior to screening visit; Already had surgery in this study; 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.