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

NCT05935358 · tracked via the Priya Life Science UK tracker

Sponsor

Octapharma

Phase

Phase 4

Started

2023-11-28

Last updated

2026-05-12

Condition(s) studied

Severe Hemophilia A

Investigational drug(s) / intervention(s)

Nuwiq

Nuwiq: Nuwiq is a purified B-domain-deleted FVIII glycoprotein synthesised by a genetically engineered human embryonic kidney cell line (HEK 293F).

Study summary

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

Eligibility

Sex

MALE

Min age

12 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Overall haemostatic efficacy — During surgery and until completion of wound healing (e.g. removal of sutures, cessation of drainage, etc.) as defined by the investigator, during the study duration of 30 ± 3 days after the day of surgical procedure
Overall haemostatic efficacy of treatment measured as binary "success" or "failure". The overall perioperative haemostatic efficacy of Nuwiq will be adjudicated by an Independent Data Monitoring Committee (IDMC) and determined using a composite assessment algorithm that considers the surgeon's assessment of intraoperative haemostatic efficacy and the investigator's assessment of postoperative haemostatic efficacy to classify the overall haemostatic efficacy as success or failure.

Trial sites (18)

Facility	City	Region	Status
UT Southwestern Medical Center	Dallas	Texas	Recruiting
University Hospital Centre Zagreb	Zagreb	Croatia	Recruiting
Helsinki University Hospital	Helsinki	Finland	Recruiting
CHU de Nantes Hôtel-Dieu	Nantes	France	Recruiting
CHRU de Tours	Tours	France	Recruiting
Vivantes Klinikum im Friedrichshein (KFH)	Berlin	Germany	Recruiting
Gerinnungszentrum Rhein-Ruhr	Duisburg	Germany	Recruiting
Universitätsklinikum Hamburg Eppendorf (UKE)	Hamburg	Germany	Recruiting
Christian Medical College Vellore	Vellore	Tamil Nadu	Recruiting
St. John's Medical College Hospital	Bengaluru	India	Recruiting
Azienda Ospedaliera Pugliese Ciaccio	Catanzaro	Italy	Recruiting
Azienda Ospedaliero Universitaria Careggi - Centro Emofilia	Florence	Italy	Recruiting
Centro Trombosi e Malattie Emorragiche, ITCCS Humanitas Research Hospital	Milan	Italy	Recruiting
Centre for Haemopilia, Institute for transfusion medicine of Republic of North Macedonia	Skopje	North Macedonia	Recruiting
Clinical Center for Serbia Belgrade	Belgrade	Serbia	Recruiting
Hospital Universitario La Paz	Madrid	Spain	Recruiting
Hospital Universitario Virgen del Rocio	Seville	Spain	Recruiting
St. James's University Hospital	Leeds	United Kingdom	Not Yet Recruiting

More Octapharma trials in the UK

Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass Recruiting

Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery Recruiting

Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients Recruiting

Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery Recruiting

Other trials for the same condition

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Emicizumab in Participants From Birth to 12 Months of Age With Hemophilia A Without Inhibitors Active, not recruiting

A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05935358 on ClinicalTrials.gov ↗ ← All trials in the UK