Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients
Recruiting now
Conditions studied: Haemophilia A
In brief
International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally treated severe haemophilia A patients in routine clinical practice.
Key facts
- Study ID
- NCT03695978
- Run by
- Octapharma
- People needed
- 200
- Starts
- 2018-02-13
- Expected to finish
- 2030-06-01
- Last updated by the study team
- 2026-06-02
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female patients of any age and ethnicity
- Severe haemophilia A (FVIII:C<1%)
- Decision to prescribe Octapharma's FVIII concentrate before enrollment into the study
- Either
- No previous treatment with FVIII concentrates or other blood products containing FVIII (PUPs) OR
- Less than 5 Exposure Days (EDs) to FVIII concentrates or other blood products containing FVIII (MTPs), if
- data are available on all previous treatment, AND
- they did not develop an inhibitor at any time point, OR
- they developed an inhibitor during treatment with an Octapharma FVIII concentrate AND continue treatment with THIS Octapharma FVIII concentrate (in the presence or absence of emicizumab).
- Voluntarily given, fully informed written and signed consent obtained before any study-related data documentation is conducted (obtained from the patient's parent/legal guardian)
You may not qualify if…
- Diagnosis with a coagulation disorder other than haemophilia A
- Concomitant treatment with any systemic immunosuppressive drug
- Participation in an interventional clinical trial during the time period evaluated
- Participation in another non-interventional study of Octapharma
Where it is running
- University of Debrecen Department of Pediatrics — Debrecen, Hungary (enrolling)
- Center for Thrombosis and Hemorrhagic Diseases, IRCCS Humanitas Research Hospital — Milan, Italy (enrolling)
- Coagulation Research Centre GmbH — Duisburg, Germany (enrolling)
- Heim Pál National Pediatric Institute Department of Oncology and Hematology — Budapest, Hungary (enrolling)
- Azienda Ospedaliera-Universitaria Policlinico "Vittorio Emanuele", Centro di Riferimento Regionale per la Prevenzione, Diagnosi e Cura delle Malattie Rare della Coagulazione nel Bambino e neel'Adulto. U.O.C Ematologia con trapianto di Midollo Osseo — Catania, Italy (enrolling)
- Ospedale Maggiore Policlinico — Milan, Italy (enrolling)
- Institute of Experimental Haematology and Transfusion Medicine (IHT) University Clinic Bonn (AöR) — Bonn, Germany (enrolling)
- Republican Scientific and Practical Centre of Children Oncology, Hematology and Immunology — Minsk, Belarus (enrolling)
- Hôpital Universitaire des Enfants Reine Fabiola — Brussels, Belgium (enrolling)
- Cliniques Universitaires Saint-Luc — Brussels, Belgium (enrolling)
- Ospedale Pediatrico "Giovani XXIII" — Bari, Italy (enrolling)
- Policlinico Sant'Orsola Malpighi — Bologna, Italy (enrolling)
- Azienda Ospedaliero Universitaria Careggi — Florence, Italy (enrolling)
- University Hospital Centre Zagreb — Zagreb, Croatia (enrolling)
- University of Miami Miller School of Medicine — Miami, Florida, United States (enrolling)
- CENTRE HOSPITALIER UNIVERSITAIRE de BESANCON — Besançon, France (enrolling)
- The Centre Hospitalier Métropole Savoie — Chambéry, France (enrolling)
- CHRU Tours - Hôpital Trousseau — Chambray-lès-Tours, France (enrolling)
- Centre Régional de Traitement de l'hémophilie — Le Mans, France (enrolling)
- Hopital Simone Veil Groupement Hospitalier Eaubonne-Montmorency — Montmorency, France (enrolling)
- CHU Hotel Dieu, Centre de Traitment de l'Hemophilie — Nantes, France (enrolling)
- Hôspital Necker Enfants Malades — Paris, France (enrolling)
- CHRU Hopital Nord, Secretariat de pediatre, bat E niv +3 — Saint-Priest-en-Jarez, France (enrolling)
- Cliniques Universitaires Saint-Luc — Brussels, Belgium (enrolling)
- Policlinico Umberto I — Rome, Italy (enrolling)
Full record on ClinicalTrials.gov
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