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Taking peoplePhase 4

Nuwiq treatment during surgery for people with haemophilia A

Tests Nuwiq with emicizumab to control bleeding in severe haemophilia A surgery.

Key facts

Who runs it
Octapharma AG
Where
Catanzaro, Florence, and Rozzano, ItalySee the 3 sitesAlso in 5 other countries, 8 sites
Registry title
Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis study (NuPOWER)
Status
Recruiting
Phase
Phase 4
People taking part
45 people, planned
Started
19 Oct 2023
Planned end
1 Mar 2025
Type of study
Interventional
Record updated
25 September 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for males aged 12 or older with severe haemophilia A who use emicizumab regularly and need a planned major surgery. They will receive Nuwiq around the surgery.

Age
At least 12 years old
Sex
Males only
Disease stage
Severe haemophilia A (FVIII activity below 1%)
Earlier treatment
Must have used FVIII products for at least 150 exposure days. Must have been on regular emicizumab prophylaxis for at least 3 months before a planned major elective surgery that needs FVIII treatment.
Biomarker or test result
FVIII activity [FVIII:C] <1%

Main reasons for not taking part

  • A bleeding disorder other than haemophilia A
  • Present or past FVIII inhibitor (≥0.6 Bethesda units [BU]/mL)
  • Severe liver or kidney disease (ALT and/or AST more than 5 times the upper limit of normal, or creatinine >120 μmol/L (1.36 mg/dL))
  • Taking part in another interventional clinical trial, or any investigational product within 30 days before screening
  • Known allergy to Nuwiq's active substance or its other ingredients

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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 3 months prior to a scheduled major elective surgery requiring FVIII treatment
  • Freely given written informed consent

Who cannot take part

  • Present or past FVIII inhibitor (≥0.6 Bethesda units [BU]/mL) according to medical history
  • Treatment with any investigational product within 30 days prior to screening visit
  • Already had surgery in this study
  • Coagulation disorder other than haemophilia A
  • Severe liver or kidney disease (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] levels >5 times the upper limit of normal; or creatinine >120 μmol/L)
  • Known hypersensitivity to Nuwiq’s active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
  • Current participation in another interventional clinical trial

Where in Italy

Also in 5 other countries, 8 sites

  • Azienda Ospedaliera Pugliese CiaccioCatanzaro, ItalyNo longer taking part
  • Careggi University HospitalFlorence, ItalyNo longer taking part
  • Humanitas Research HospitalRozzano, ItalyNo longer taking part

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis study (NuPOWER)
Plain-language title
Nuwiq treatment during surgery for people with haemophilia AGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
25 September 2025