NCT01692925

Investigation of the Pharmacokinetics of Turoctocog Alfa in Subjects With Haemophilia A

Multi-centre, Open-labelled Trial Investigating the Pharmacokinetics of Four Lots of Turoctocog Alfa in Subjects With Haemophilia A

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Congenital Bleeding Disorder
• Haemophilia A

Interventions

Type	Name	Description
DRUG	turoctocog alfa	Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
DRUG	turoctocog alfa	Trial product, 3000 IU/vial will be administered as an i.v. (intravenous) bolus injection.

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-09-26
• Last updated: 2017-02-10

Locations

5 sites across 4 countries: Germany, Latvia, Malaysia, Spain