Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients
Key facts
- Where
- Bari, Bologna, Castelfranco Veneto, Catania, Florence, Milan, Padova, Rome, Torino, and Turin, ItalySee the 11 sites
Where in Italy
- Ospedale Pediatrico "Giovani XXIII"Bari, ItalyTaking people
- Policlinico Sant'Orsola-MalpighiBologna, ItalyTaking people
- Ospedale San GiacomoCastelfranco Veneto, ItalyNo longer taking part
- 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 OsseoCatania, ItalyTaking people
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- Center for Thrombosis and Hemorrhagic Diseases, IRCCS Humanitas Research HospitalMilan, ItalyTaking people
- Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Centro Emofilia - AUO di PadovaPadova, ItalyNo longer taking part
- Policlinico Umberto IRome, ItalyTaking people
- C.tro Emofilia A.O. Città della salute e della scienza di Torino, Ospedale Regina MargheritaTorino, ItalyTaking people
- Ospedale Regina MargheritaTurin, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Octapharma
- Trial code
- NCT03695978
- Record updated
- 2 June 2026
- Original description
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.Read full original descriptionShow less
Practical Utilisation of Octapharma FVIII Concentrates in Previously Untreated & Minimally Treated Haemophilia A Patients Entering Routine Clinical Treatment With Nuwiq, Octanate or Wilate - Efficacy & Safety Observational Study-Protect-NOW
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.
Inclusion: 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).
Exclusion: Concomitant treatment with any systemic immunosuppressive drug; Diagnosis with a coagulation disorder other than haemophilia A; Participation in an interventional clinical trial during the time period evaluated; Participation in another non-interventional study of Octapharma.