Nuwiq dosing to prevent bleeding in girls and women with haemophilia A during surgery
Tests Nuwiq, a clotting factor, to prevent bleeding during surgery in females with haemophilia A.
Plain-language title generated from the registry record
Registry title: Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery
Key facts
- Where
- Bern, SwitzerlandSee the site
- Phase
- Phase 4
Where in Switzerland
- Insel Spital BernBern, SwitzerlandNot yet recruiting
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
- NCT05936580
- Record updated
- 12 May 2026
- Original description
Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgeryRead full original descriptionShow less
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)
Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery
Inclusion: Women/girls with haemophilia A (FVIII:C ≥1-<40%) according to medical history. Additionally, women/girls with documented FVIII activity levels between ≥ 40% and 50% may be included if there is a documented history of clinically significant bleeding episodes consistent with haemophilia A; and/or either documented prior treatment with FVIII concentrates or a 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); At least 12 years of age; Scheduled to undergo major surgery* requiring FVIII treatment, including elective and emergency procedures and caesarean section in pregnant women with haemophilia A; 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); 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); Pregnancy, except in participants with a planned caesarean section; Current participation in another interventional clinical trial.