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.