This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog alfa (a human recombinant coagulation factor VIII (FVIII)) in subjects with haemophilia A.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
Trial product, 3000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
Novo Nordisk Investigational Site
Berlin, Germany
Novo Nordisk Investigational Site
Frankfurt/M., Germany
Novo Nordisk Investigational Site
Riga, Latvia
Novo Nordisk Investigational Site
Kuala Lumpur, Malaysia
Dose normalised area under the curve (AUC/actual dose) based on chromogenic assay
Time frame: up to 48 hours after i.v. administration
Dose normalised area under the FVIII activity-time curve (AUC/actual dose) based on one stage clot assay
Time frame: up to 48 hours after i.v. administration
Incremental recovery (IR30min) (defined as the peak FVIII level recorded 30 min after injection and reported as[IU/mL]/[IU/kg])
Time frame: up to 48 hours after i.v. administration
Area under the FVIII activity-time curve (AUC)
Time frame: up to 48 hours after i.v. administration
Terminal half-life of FVIII (t½)
Time frame: up to 48 hours after i.v. administration
Clearance of FVIII (CL)
Time frame: up to 48 hours after i.v. administration
Incidence of adverse events (AEs) including FVIII inhibitors
Time frame: After approximately 3 months (at end of trial)
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Novo Nordisk Investigational Site
Madrid, Spain