Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Octapharma

Criteria

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 3 months 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 product (IP) within 30 days prior to screening visit