Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A

Inclusion Criteria:

- Age below 6 years

- Informed consent obtained before any trial-related activities (trial-related
activities are any procedure that would not have been performed during normal
management of the patient)

- Male patients diagnosed with congenital severe haemophilia A (FVIII level equal to or
below 1%)

- No prior use of purified clotting factor products (previous exposure, equal to or less
than 5 ED to blood components, e.g. cryoprecipitate, fresh frozen plasma, is accepted)
including commercially available NovoEight® /Novoeight®

Exclusion Criteria:

- Known or suspected allergy to hamster protein or intolerance to trial product(s) or
related products

- Previous participation in this trial defined as withdrawal after administration of
trial product

- Congenital or acquired coagulation disorders other than haemophilia A

- Any history of Factor VIII inhibitor

- Ongoing treatment or planned treatment during the trial with immunomodulatory agents
(e.g. intravenous immunoglobulin (IVIG), routine systemic corticosteroids)