This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia A subjects, investigating the action and safety of the drugs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Subjects will receive Advate® at a dose of 50 IU/kg body weight in the first session
After a washout period of 4 days, subjects will subsequently receive turoctocog alfa (recombinant factor VIII (N8)) at a dose of 50 IU/kg body weight in the second session
Novo Nordisk Investigational Site
Berlin, Germany
Novo Nordisk Investigational Site
Hanover, Germany
Novo Nordisk Investigational Site
Tel Litwinsky, Israel
Novo Nordisk Investigational Site
Florence, Italy
Recovery of FVIII 30 min after administration, half-life, AUC, and clearance
Time frame: at 30 days
Inhibitor development
Time frame: at 30 days
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Novo Nordisk Investigational Site
Milan, Italy
Novo Nordisk Investigational Site
Madrid, Spain
Novo Nordisk Investigational Site
Zurich, Switzerland