NCT05935358

Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study

Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study (NuPOWER)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Octapharma · Industry
• Sex: Male
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis

Detailed description

Patients with severe haemophilia A receiving emicizumab will often need concomitant FVIII to provide haemostatic cover during major surgery. This prospective, open-label, uncontrolled, single-arm, multinational, multicentre study aims to evaluate the overall perioperative haemostatic efficacy of Nuwiq, a recombinant factor VIII, in combination with emicizumab prophylaxis in male patients over 12 with severe haemophilia A undergoing major surgery.

Conditions

• Severe Hemophilia A

Interventions

Type	Name	Description
DRUG	Nuwiq	Nuwiq is a purified B-domain-deleted FVIII glycoprotein synthesised by a genetically engineered human embryonic kidney cell line (HEK 293F).

Timeline

• Start date: 2023-11-28
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2023-07-07
• Last updated: 2025-10-24

Locations

18 sites across 11 countries: United States, Croatia, Finland, France, Germany, India, Italy, North Macedonia, Serbia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study