Real-life use of Nuwiq, Octanate and Wilate in people with new haemophilia A treatment
Observes how Nuwiq, Octanate and Wilate work in people with severe haemophilia A.
Plain-language title generated from the registry record
Registry title: Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients
Key facts
- Where
- Alicante, Barcelona, Málaga, Palma de Mallorca, and Valencia, SpainSee the 5 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people of any age with severe haemophilia A who are starting treatment with an Octapharma FVIII product (Nuwiq, Octanate or Wilate). They have had no FVIII treatment before, or very little.
- Age
- Any age
- Sex
- Men and women
- Disease stage
- Severe haemophilia A (FVIII:C<1%)
- Earlier treatment
- No earlier treatment with FVIII products, or fewer than 5 Exposure Days. Treatment must have been decided before joining. Earlier treatment must be fully documented, and no inhibitor may have developed. An inhibitor is allowed only if it appeared during an Octapharma FVIII product and the person continues that same product.
Main reasons for not taking part
- A bleeding disorder other than haemophilia A
- Taking any systemic immunosuppressive drug at the same time
- Taking part in an interventional clinical trial in the studied period
- Taking part in another non-interventional study of Octapharma
Read by machine on 9 November 2026.
Where in Spain
- Hospital General Universitario de Alicante Hematología y HemoterapiaAlicante, SpainContact: Pascual Marco VeraTaking people
- Hospital Universitari Vall D'Hebrón, Unitat d'HemofiliaBarcelona, SpainContact: Olga Benitez HidalgoTaking people
- HRU MalagaMálaga, SpainContact: Cristina Solomon, MDNot yet recruiting
- Universitary Hospital Son Espases (Hematology Service)Palma de Mallorca, SpainContact: Cristina Solomon, MDNo longer taking part
- Hospital Universitario Y Politecnico La FeValencia, SpainContact: Cristina Solomon, MDNo 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.