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Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis study (NuPOWER)
EU CTIS ID: 2022-502060-21-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Coagulation disorder other than haemophilia A.
- Present or past FVIII inhibitor (≥0.6 Bethesda units [BU]/mL) according to medical history.
- 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).
- Current participation in another interventional clinical trial.
- Treatment with any investigational product within 30 days prior to screening visit.
- Known hypersensitivity to Nuwiq’s active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
See the full eligibility criteria
- 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.
- Coagulation disorder other than haemophilia A.
- Present or past FVIII inhibitor (≥0.6 Bethesda units [BU]/mL) according to medical history.
- 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).
- Current participation in another interventional clinical trial.
- Treatment with any investigational product within 30 days prior to screening visit.
- Known hypersensitivity to Nuwiq’s active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
- Already had surgery in this study
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.