uwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis study (NuPOWER)

Phase 1

• Conditions: Haemophilia A; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: CTIS2022-502060-21-00
• Lead Sponsor: Octapharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-31
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 50

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.

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)., 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified