Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Pr
Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis
| Condition(s) | Severe Hemophilia A |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis |
| Who can participate | 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 |
| Ages | 12 Years |
| Sex | Male |
| Lead sponsor | Octapharma |
| Locations | Dallas, Texas, United States; Zagreb, Croatia; Helsinki, Finland; Nantes, France; Tours, France; Berlin, Germany (+12 more sites) |
| Start date | 2023-11-28 |
| NCT ID | NCT05935358 |
| Official listing | https://clinicaltrials.gov/study/NCT05935358 |