RecruitingPhase 4NCT05935358
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)
Sponsor
Octapharma
Enrollment
28 participants
Start Date
Nov 28, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis
Eligibility
Sex: MALEMin Age: 12 Years
Inclusion Criteria5
- 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 Criteria7
- 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
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Interventions
DRUGNuwiq
Nuwiq is a purified B-domain-deleted FVIII glycoprotein synthesised by a genetically engineered human embryonic kidney cell line (HEK 293F).
Locations(18)
View Full Details on ClinicalTrials.gov
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NCT05935358
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