NuPOWER
Research type
Research Study
Full title
Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis study (NuPOWER)
IRAS ID
1008535
Contact name
Sigurd Knaub
Contact email
Sponsor organisation
Octapharma AG
Eudract number
2022-502060-21
Clinicaltrials.gov Identifier
Research summary
This is a phase 4, prospective, open-label, uncontrolled, single-arm, multinational, multicentre study that will be conducted at approximately 15 sites worldwide. All patients will be receiving regular prophylaxis with emicizumab and be scheduled to undergo a major surgical procedure during which concomitant Nuwiq will be administered. A maximum of 28 patients will be enrolled in order to document 26 evaluable major surgeries (each subject can have only one surgery in the study). Each patient will be in the study from the time of the screening visit until 30 days after the day of the surgical procedure or at the day of discharge (whichever comes last). The primary objective of this study is to evaluate the overall perioperative haemostatic efficacy of Nuwiq, in combination with ongoing emicizumab prophylaxis, in patients with severe haemophilia A undergoing major surgery.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
23/SC/0428
Date of REC Opinion
29 Jan 2024
REC opinion
Further Information Favourable Opinion