Investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe haemophilia A
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
21
Administered as intravenous injections at a dose of 50 U/kg. Patients will receive each product in a randomised cross-over design for comparison of the pharmacokinetics between turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process.
Novo Nordisk Investigational Site
Torrance, California, United States
Novo Nordisk Investigational Site
Iowa City, Iowa, United States
Novo Nordisk Investigational Site
Baltimore, Maryland, United States
Novo Nordisk Investigational Site
Dayton, Ohio, United States
Novo Nordisk Investigational Site
Nashville, Tennessee, United States
Novo Nordisk Investigational Site
Århus N, Denmark
Novo Nordisk Investigational Site
Bron, France
Novo Nordisk Investigational Site
Nantes, France
Novo Nordisk Investigational Site
Berlin, Germany
Novo Nordisk Investigational Site
Frankfurt/M., Germany
...and 4 more locations
Area under the FVIII activity-time curve
Time frame: From 0 to 96 hours post injection
FVIII activity 30 min post administration - dose normalised to 50 U/kg
Time frame: From time of trial product administration to 96 hours post-dose
Area under the FVIII activity-time curve from 0 to infinity
Time frame: From time of trial product administration to 96 hours post-dose
Clearance in blood plasma of FVIII activity
Time frame: From time of trial product administration to 96 hours post-dose
Incremental recovery in blood plasma of FVIII activity
Time frame: From time of trial product administration to 96 hours post-dose
Terminal half-life
Time frame: From time of trial product administration to 96 hours post-dose
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