Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study
Recruiting now · Phase 4
Conditions studied: Severe Hemophilia A
In brief
Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis
Key facts
- Study ID
- NCT05935358
- Run by
- Octapharma
- People needed
- 28
- Starts
- 2023-11-28
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2026-05-12
Who can join
Age: 12 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
- University Hospital Centre Zagreb — Zagreb, Croatia (enrolling)
- Helsinki University Hospital — Helsinki, Finland (enrolling)
- CHU de Nantes Hôtel-Dieu — Nantes, France (enrolling)
- CHRU de Tours — Tours, France (enrolling)
- Vivantes Klinikum im Friedrichshein (KFH) — Berlin, Germany (enrolling)
- Gerinnungszentrum Rhein-Ruhr — Duisburg, Germany (enrolling)
- Universitätsklinikum Hamburg Eppendorf (UKE) — Hamburg, Germany (enrolling)
- Christian Medical College Vellore — Vellore, Tamil Nadu, India (enrolling)
- St. John's Medical College Hospital — Bengaluru, India (enrolling)
- Azienda Ospedaliera Pugliese Ciaccio — Catanzaro, Italy (enrolling)
- Azienda Ospedaliero Universitaria Careggi - Centro Emofilia — Florence, Italy (enrolling)
- Centro Trombosi e Malattie Emorragiche, ITCCS Humanitas Research Hospital — Milan, Italy (enrolling)
- Centre for Haemopilia, Institute for transfusion medicine of Republic of North Macedonia — Skopje, North Macedonia (enrolling)
- Clinical Center for Serbia Belgrade — Belgrade, Serbia (enrolling)
- Hospital Universitario La Paz — Madrid, Spain (enrolling)
- Hospital Universitario Virgen del Rocio — Seville, Spain (enrolling)
- St. James's University Hospital — Leeds, United Kingdom
Full record on ClinicalTrials.gov
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