Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients

ConditionHaemophilia A
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorOctapharma

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 3 trial groups
Group A: Nuwiq
Group B: Octanate
Group C: Wilate

Trial outcomes

Primary outcomes

1

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

Time frame
100 exposure days
2

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.

Time frame
100 exposure days

Secondary outcomes

1

Dosage of FVIII concentrates

For each individual FVIII injection the dose will be recorded.

Time frame
100 exposure days
2

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'.

Time frame
100 exposure days

Other outcomes

Sponsors and contacts

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