2022-502060-21-00RecruitingPhase 4
Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis study (NuPOWER)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 31 Jan 2023
- Start date
- 19 Oct 2023
- Lead sponsor
- Octapharma AG
- Diseases
- Haemophilia
- EU CT number
- 2022-502060-21-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 45
- 11 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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)
- 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
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Coagulation disorder other than haemophilia A.
Lab values
- 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)
Other
- Current participation in another interventional clinical trial.
Who the study is looking for
- 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.
Sex: Male · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vivantes Netzwerk fuer Gesundheit GmbH | Berlin | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany | Recruiting |
| Hospital Universitario La Paz | Madrid | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Recruiting |
| HUS-Yhtymae | Helsinki | Finland | Recruiting |
| Centre Hospitalier Universitaire de Nantes | Nantes | France | Recruiting |
| Centre Hospitalier Régional Universitaire de Tours | Tours | France | Recruiting |
| University Hospital Centre Zagreb | Grad Zagreb | Croatia | Recruiting |
| Azienda Ospedaliera Pugliese Ciaccio | Catanzaro | Italy | Completed |
| Careggi University Hospital | Florence | Italy | Completed |
| Humanitas Research Hospital | Rozzano | Italy | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.