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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.

Key facts

Who runs it
Octapharma
Where
Brussels, BelgiumSee the 2 sitesAlso in 17 other countries, 56 sites
Trial code
Registry title
Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients
Status
Recruiting
People taking part
200 people, planned
Started
13 Feb 2018
Expected to end
Jun 2030
Type of study
Observational, 3 groups
Record updated
2 June 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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

Where in Belgium

Also in 17 other countries, 56 sites

  • Cliniques universitaires Saint-LucBrussels, BelgiumContact: An Van DammeTaking people
  • Hòpital Universitaire des Enfants Reine FabiolaBrussels, BelgiumContact: Phu Quac LeTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Nuwiq

    All patients receiving Nuwiq (recombinant FVIII)

  • Octanate

    All patients receiving Octanate (plasma derived FVIII)

  • Wilate

    All patients receiving Wilate (plasma derived FVIII/von Willebrand factor \[VWF\])

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Real-life use of Nuwiq, Octanate and Wilate in people with new haemophilia A treatmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
2 June 2026