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)

GENA-23

Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery

2024-02-01

2025-12-01

2025-12-01

Not yet recruiting

Early phase I

28

Inclusion Criteria: 1. Women/girls with haemophilia A (FVIII:C ≥1-\<40%) according to medical history 2. At least 12 years of age 3. Scheduled to undergo major elective surgery requiring FVIII treatment 4. Freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations Exclusion Criteria: 1. Coagulation disorder other than haemophilia A 2. Present or past FVIII inhibitor (≥0.6 Bethesda units \[BU\]/mL) 3. 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) 4. Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188) 5. Pregnancy 6. Already had surgery in this study 7. Current participation in another interventional clinical trial 8. Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 28, 'type': 'ESTIMATED'}}

2024-01-23