Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis study (NuPOWER)

Conditions

Haemophilia A

Brief summary

The primary endpoint is the overall haemostatic efficacy (“success” or “failure”) of Nuwiq in severe haemophilia A patients receiving emicizumab prophylaxis and undergoing major surgery.

Detailed description

Assessment of intraoperative haemostatic efficacy of Nuwiq using a 4-point ordinal scale., Assessment of postoperative haemostatic efficacy of Nuwiq using a 4-point ordinal scale., Perioperative FVIII plasma levels immediately before (≤30 minutes) and after (15-30 minutes) Nuwiq injections., Perioperative haemostatic efficacy assessed using the 4-point scale recommended by the WFH., Incidence of adverse events (AEs)., Incidence of thrombotic events., Incidence of FVIII inhibitor formation., Number of allogeneic blood products (red blood cells, platelets, and other blood products) transfused, Perioperative TG immediately before (≤30 minutes) and after (15-30 minutes) Nuwiq injections

Srivastava A, Kanny A, Langer F, Kubicek-Hofmann C, Álvarez Román MT, Núñez Vázquez R, Boban A, Dejanova-Ilijevska V, Miljić P, Garcia J, Halimeh S, Drillaud N, Valentin JB, Mancuso ME, Castaman G, Santoro RC, Lehtinen AE, Abraham A, Hashimoto M, Knaub S.

2025-10-28

10.1136/bmjopen-2025-102657

Interventions

DRUGNuwiq 2500 IU powder and solvent for solution for injection

DRUGNuwiq 4000 IU powder and solvent for solution for injection

DRUGNuwiq 1000 IU powder and solvent for solution for injection

DRUGNuwiq 1500 IU powder and solvent for solution for injection

DRUGNuwiq 3000 IU powder and solvent for solution for injection

DRUGNuwiq 250 IU powder and solvent for solution for injection

DRUGNuwiq 500 IU powder and solvent for solution for injection

DRUGNuwiq 2000 IU powder and solvent for solution for injection

Eligibility

Sex/Gender

Male

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the overall haemostatic efficacy (“success” or “failure”) of Nuwiq in severe haemophilia A patients receiving emicizumab prophylaxis and undergoing major surgery.	—

Secondary

Measure	Time frame
Assessment of intraoperative haemostatic efficacy of Nuwiq using a 4-point ordinal scale., Assessment of postoperative haemostatic efficacy of Nuwiq using a 4-point ordinal scale., Perioperative FVIII plasma levels immediately before (≤30 minutes) and after (15-30 minutes) Nuwiq injections., Perioperative haemostatic efficacy assessed using the 4-point scale recommended by the WFH., Incidence of adverse events (AEs)., Incidence of thrombotic events., Incidence of FVIII inhibitor formation., Number of allogeneic blood products (red blood cells, platelets, and other blood products) transfused, Perioperative TG immediately before (≤30 minutes) and after (15-30 minutes) Nuwiq injections	—

Measure

Time frame

Assessment of intraoperative haemostatic efficacy of Nuwiq using a 4-point ordinal scale., Assessment of postoperative haemostatic efficacy of Nuwiq using a 4-point ordinal scale., Perioperative FVIII plasma levels immediately before (≤30 minutes) and after (15-30 minutes) Nuwiq injections., Perioperative haemostatic efficacy assessed using the 4-point scale recommended by the WFH., Incidence of adverse events (AEs)., Incidence of thrombotic events., Incidence of FVIII inhibitor formation., Number of allogeneic blood products (red blood cells, platelets, and other blood products) transfused, Perioperative TG immediately before (≤30 minutes) and after (15-30 minutes) Nuwiq injections

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Countries

Croatia, Finland, France, Germany, Italy, Spain

Outcome results

None listed