Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients
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
Octapharma
200 participants
Feb 13, 2018
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- 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 Criteria4
- 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
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Locations(55)
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NCT03695978