Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study (NuPOWER)
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 12
Healthy Volunteers: f
View:
• 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 1 month prior to a scheduled 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 Southwestern Medical Center
RECRUITING
Dallas
Other Locations
Croatia
University Hospital Centre Zagreb
RECRUITING
Zagreb
Finland
Helsinki University Hospital
RECRUITING
Helsinki
France
CHU de Nantes Hôtel-Dieu
RECRUITING
Nantes
CHRU de Tours
RECRUITING
Tours
Germany
Vivantes Klinikum im Friedrichshein (KFH)
RECRUITING
Berlin
Gerinnungszentrum Rhein-Ruhr
RECRUITING
Duisburg
Universitätsklinikum Hamburg Eppendorf (UKE)
RECRUITING
Hamburg
India
St. John's Medical College Hospital
NOT_YET_RECRUITING
Bengaluru
Christian Medical College Vellore
RECRUITING
Vellore
Italy
Azienda Ospedaliera Pugliese Ciaccio
RECRUITING
Catanzaro
Azienda Ospedaliero Universitaria Careggi - Centro Emofilia
RECRUITING
Florence
Centro Trombosi e Malattie Emorragiche, ITCCS Humanitas Research Hospital
RECRUITING
Milan
Serbia
Clinical Center for Serbia Belgrade
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, PhD
Sigurd.Knaub@octapharma.com
+41 554512141
Time Frame
Start Date: 2023-11-28
Estimated Completion Date: 2026-08
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