Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A

A Multicentre, Open-label Trial Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A

This trial is conducted globally. The aim of this trial is evaluating the pharmacokinetics (the exposure of the trial drug in the body) of NovoEight® (turoctocog alfa) in relation to BMI (body mass index) in subjects with haemophilia A.

Inclusion Criteria:

• Male, age at least 18 years at the time of signing informed consent
• History of more than 150 exposure days to any factor VIII products
• Subjects with the diagnosis of congenital haemophilia A with factor VIII activity below 1%, based on medical records

Exclusion Criteria:

• Known history of factor VIII inhibitors
• Inhibitors to factor VIII (above or equal to 0.6 BU (Bethesda units)) at screening measured by the Nijmegen modified Bethesda method
• Known congenital or acquired coagulation disorders other than haemophilia A
• Previous participation in pharmacokinetic sessions with turoctocog alfa in another trial