RECRUITINGPhase 4INTERVENTIONAL
Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study
Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study (NuPOWER)
About This Trial
Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations
Who Should NOT Join This Trial:
- 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)
- 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
- Current participation in another interventional clinical trial
- Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion 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 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
Exclusion Criteria:
* 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)
* 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
* Current participation in another interventional clinical trial
* Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit
Treatments Being Tested
DRUG
Nuwiq
Nuwiq is a purified B-domain-deleted FVIII glycoprotein synthesised by a genetically engineered human embryonic kidney cell line (HEK 293F).
Locations (18)
UT Southwestern Medical Center
Dallas, Texas, United States
University Hospital Centre Zagreb
Zagreb, Croatia
Helsinki University Hospital
Helsinki, Finland
CHU de Nantes Hôtel-Dieu
Nantes, France
CHRU de Tours
Tours, France
Vivantes Klinikum im Friedrichshein (KFH)
Berlin, Germany
Gerinnungszentrum Rhein-Ruhr
Duisburg, Germany
Universitätsklinikum Hamburg Eppendorf (UKE)
Hamburg, Germany
Christian Medical College Vellore
Vellore, Tamil Nadu, India
St. John's Medical College Hospital
Bengaluru, India
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, Italy
Azienda Ospedaliero Universitaria Careggi - Centro Emofilia
Florence, Italy
Centro Trombosi e Malattie Emorragiche, ITCCS Humanitas Research Hospital
Milan, Italy
Centre for Haemopilia, Institute for transfusion medicine of Republic of North Macedonia
Skopje, North Macedonia
Clinical Center for Serbia Belgrade
Belgrade, Serbia
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
St. James's University Hospital
Leeds, United Kingdom