NCT01138501

Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A

A Multi-Centre, Open-Label, Non-Controlled Trial on Safety and Efficacy of N8 in Previously Treated Paediatric Patients With Haemophilia A

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 11 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Asia, Europe, and North and South America. The aim of this clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in male previously treated paediatric subjects with haemophilia A.

Conditions

• Congenital Bleeding Disorder
• Haemophilia A

Interventions

Type	Name	Description
DRUG	turoctocog alfa	Subjects will be treated 3 times per week or every second day with intravenous injections of turoctocog alfa. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen.
DRUG	turoctocog alfa	Subjects will undergo half-life evaluation of their current factor VIII product and pharmacokinetic session with turoctocog alfa before entering preventive treatment (subjects with available evaluation of terminal half-life within the last year are to be excluded from receiving factor VIII). Intravenous injections. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen.

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-06-07
• Last updated: 2017-03-17
• Results posted: 2014-06-11

Locations

38 sites across 13 countries: United States, Brazil, Italy, Japan, Lithuania, Malaysia, North Macedonia, Poland, Puerto Rico, Russia, Serbia, Taiwan, Turkey (Türkiye)