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)
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 12
Healthy Volunteers: f
View:
• Women/girls with haemophilia A (FVIII:C ≥1-\<40%) according to medical history
• At least 12 years of age
• Scheduled to undergo 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
Locations
United States
Texas
UT Health San Antonio
RECRUITING
San Antonio
Other Locations
Finland
Helsinki University Hospital,Coagulation Disorder Unit
RECRUITING
Helsinki
France
Avenue de la République
RECRUITING
Chambray-lès-tours
CHU de Nantes Hôtel-Dieu
RECRUITING
Nantes
Germany
Universitätsklinikum Bonn,Institut für Experimentelle Haematologie und Transfusionsmedizin
RECRUITING
Bonn
Gerinnungszentrum Rhein-Ruhr
RECRUITING
Duisburg
Universitätsklinikum Hamburg Eppendorf,II. Medizinische Klinik und Poliklinik
RECRUITING
Hamburg
Italy
Aziendo Ospedaliera Puglieze Ciaccio
RECRUITING
Catanzaro
Policlinico P. Giaconne
RECRUITING
Palermo
Serbia
Clinical Center for Serbia
RECRUITING
Belgrade
Spain
Hospital Universitario la Paz
RECRUITING
Madrid
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
United Kingdom
St. James's University Hospital
NOT_YET_RECRUITING
Leeds
Contact Information
Primary
Sigurd Knaub
Sigurd.Knaub@octapharma.ch
+41 554512141
Time Frame
Start Date: 2025-09
Estimated Completion Date: 2027-02
Participants
Target number of participants: 28
Treatments
Experimental: Nuwiq
All patients receiving Nuwiq (recombinant FVIII). Nuwiq will be administered intravenously in accordance with the relevant prescribing information. Treatment will be repeated as necessary every 8-24 hours until adequate wound healing, then - if required - for at least another 7 days to maintain FVIII plasma levels of 30-60 IU/dL.
Related Therapeutic Areas
Sponsors
Leads: Octapharma