Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery
Recruiting now · Phase 4
Conditions studied: Hemophilia A
In brief
Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery
Key facts
- Study ID
- NCT05936580
- Run by
- Octapharma
- People needed
- 28
- Starts
- 2026-04-01
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-05-12
Who can join
Age: 12 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Coagulation disorder other than haemophilia A
- Present or past FVIII inhibitor (≥0.6 Bethesda units [BU]/mL)
- 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
- 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
Where it is running
- UT Health San Antonio — San Antonio, Texas, United States (enrolling)
- Helsinki University Hospital,Coagulation Disorder Unit — Helsinki, Finland (enrolling)
- Avenue de la République — Chambray-lès-Tours, France (enrolling)
- CHU de Nantes Hôtel-Dieu — Nantes, France (enrolling)
- Hospital Universitario la Paz — Madrid, Spain (enrolling)
- Hospital Universitario Virgen del Rocio — Seville, Spain (enrolling)
- St. James's University Hospital — Leeds, United Kingdom (enrolling)
- Universitätsklinikum Bonn,Institut für Experimentelle Haematologie und Transfusionsmedizin — Bonn, Germany (enrolling)
- Gerinnungszentrum Rhein-Ruhr — Duisburg, Germany (enrolling)
- Universitätsklinikum Hamburg Eppendorf,II. Medizinische Klinik und Poliklinik — Hamburg, Germany (enrolling)
- Aziendo Ospedaliera "Puglieze Ciaccio" — Catanzaro, Italy (enrolling)
- Policlinico "P. Giaconne" — Palermo, Italy (enrolling)
- Clinical Center for Serbia — Belgrade, Serbia (enrolling)
- Chu de Strasbourg — Stasbourg, France
- Insel Spital Bern — Bern, Switzerland
- Centro Hospitalario Pereira Rossell — Montevideo, Uruguay
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.