Safety, Tolerability, and Pharmacokinetics Study of Turoctocog Alfa Pegol Injected Under the Skin in Patients With Haemophilia A

Inclusion Criteria:

- Male, age above or equal to 18 years at the time of signing informed consent,(part A).

- Male, age above or equal to 12 years at the time of signing informed consent,(part B).

- Diagnosis of congenital haemophilia A based on medical records (FVIII activity <1%).

- History of more than 150 exposure days to any FVIII containing products.

Exclusion Criteria:

- Previous participation in this trial. Participation is defined as signed informed
consent.

(Patients who have completed part A are allowed to also participate in part B. If so, a
separate informed consent covering part B must be signed.)

- Immune compromised patients due to human immunodeficiency virus (HIV) infection
(defined as viral load greater than or equal to 400.000 copies/mL and/or cluster of
differentiation 4+ (CD4+) lymphocyte count less than or equal to 200/μL performed at
screening or defined by medical records no older than 6 months)

- Any history of FVIII inhibitors (defined by medical records within 8 years of
randomisation)

- Inhibitors to FVIII (greater than or equal to 0.6 Bethesda unit (BU)) at screening,
measured by Nijmegen modified Bethesda method at central laboratory.