About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
A total of 200 patients, either previously untreated patients (PUPs) or minimally treated patients (MTPs), are planned to be documented in the study
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Annualised rate of breakthrough bleeds to assess efficacy in prophylactic treatment
Annualised rate of all bleeding events (BEs), including all spontaneous, traumatic and joint BEs
Incidence of Adverse Drug Reactions (ADRs)
Adverse drug reactions (ADRs) including hypersensitivity reactions will be recorded in by patients in treatment diaries, which will be reviewed at each Follow-up Visit.
Secondary outcomes
Dosage of FVIII concentrates
For each individual FVIII injection the dose will be recorded.
Overall assessment of the effectiveness of surgical prophylaxis by the treating physicians
At the end of the postoperative period, treating physicians will assess the effectiveness of surgical prophylaxis using a scale including the four items: 'excellent,' 'good,' moderate,' and 'none'.