NCT02035384

Safety and Efficacy of Turoctocog Alfa During Long-Term Treatment of Severe and Moderately Severe Haemophilia A

A Multi-centre Non-interventional Study of Safety and Efficacy of Turoctocog Alfa (rFVIII) During Long-Term Treatment of Severe and Moderately Severe Haemophilia A (FVIII =<2%)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 69 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is conducted in Europe, and North and South America. The aim of this study is to provide additional documentation of the immunogenicity, and obtain additional clinical data, of turoctocog alfa in the setting of normal clinical practise in patients previously treated with a factor VIII agent (FVIII).

Conditions

• Congenital Bleeding Disorder
• Haemophilia A

Interventions

Type	Name	Description
DRUG	turoctocog alfa	Patients will be treated with commercially available turoctocog alfa as prescribed by the treating physician in clinical daily practice and preferably according to the label for turoctocog alfa in the respective countries.

Timeline

• Start date: 2014-06-05
• Primary completion: 2020-01-15
• Completion: 2020-01-15
• First posted: 2014-01-14
• Last updated: 2020-04-27

Locations

41 sites across 15 countries: United States, Austria, Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Slovakia, Slovenia, Spain, Sweden, Switzerland