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Taking people in North MacedoniaPhase 4

Tests Nuwiq in people with severe haemophilia A having major surgery

Tests Nuwiq to prevent bleeding in people with haemophilia A undergoing surgery.

Key facts

Who runs it
Octapharma
Where
Skopje, North MacedoniaSee the siteAlso in 10 other countries, 17 sites
Trial code
Registry title
Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study
Status
Recruiting
Phase
Phase 4
People taking part
28 people, planned
Started
28 Nov 2023
Planned end
Sept 2026
Type of study
Interventional
Treatments tested
  • Nuwiq
Record updated
12 May 2026

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 have major planned surgery. It tests Nuwiq (factor VIII) to prevent bleeding.

Age
12 years or older
Sex
Males only
Disease stage
Severe haemophilia A (FVIII activity below 1%), with major planned surgery that needs FVIII treatment
Earlier treatment
At least 150 days of earlier treatment with FVIII products. On regular emicizumab for at least 1 month before the surgery.
Biomarker or test result
FVIII activity below 1%. No present or past FVIII inhibitor (0.6 Bethesda units/mL or more).

Main reasons for not taking part

  • Another bleeding disorder besides haemophilia A
  • Present or past FVIII inhibitor (0.6 Bethesda units/mL or more)
  • Severe liver or kidney disease
  • Known allergy to Nuwiq's active substance or its other ingredients
  • Taking part in another interventional trial, or an investigational medicine within 30 days before screening

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 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

Who cannot take part

  • Present or past FVIII inhibitor (≥0.6 Bethesda units [BU]/mL) according to medical history
  • Already had surgery in this study
  • Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit
  • 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 North Macedonia

Also in 10 other countries, 17 sites

  • Centre for Haemopilia, Institute for transfusion medicine of Republic of North MacedoniaSkopje, North MacedoniaContact: Sigurd Knaub, PhDTaking people

About the trial

What the trial wants to find out

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

The group in the trial

  • NuwiqTreatment being tested

    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.

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 → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study (NuPOWER)
Plain-language title
Tests Nuwiq in people with severe haemophilia A having major surgeryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
12 May 2026