NCT00837356

Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects

A Multi-centre, Multi-national Open-label Sequential Trial Comparing Pharmacokinetics and Safety of N8 and Advate® in Subjects With Haemophilia A

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 12 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Congenital Bleeding Disorder
• Haemophilia A

Interventions

Type	Name	Description
DRUG	Advate®	Subjects will receive Advate® at a dose of 50 IU/kg body weight in the first session
DRUG	turoctocog alfa	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

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2009-02-05
• Last updated: 2017-02-10

Locations

7 sites across 5 countries: Germany, Israel, Italy, Spain, Switzerland