Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A

Inclusion Criteria:

- Informed consent obtained before any trial-related activities. Trial-related
activities are any procedures that are carried out as part of the trial, including
activities to determine suitability for the trial

- Male, age below 6 years of age at the time of signing informed consent

- Diagnosis of severe haemophilia A (FVIII activity level 1%) based on medical records
or central laboratory results

- No prior use of purified clotting factor products (5 previous exposures to blood
components is acceptable)

Exclusion Criteria:

- Any history of FVIII inhibitor (defined by medical records) - Known or suspected
hypersensitivity to trial product or related products

- Previous participation in this trial. Participation is defined as first dose
administered of trial product

- Receipt of any investigational medicinal product within 30 days before screening

- Congenital or acquired coagulation disorder other than haemophilia A

- Any chronic disorder or severe disease which, in the opinion of the Investigator,
might jeopardise the patient's safety or compliance with the protocol

- Patient's parent(s')/legally acceptable representative (LAR(s')) mental incapacity,
unwillingness to cooperate, or a language barrier precluding adequate understanding
and cooperation