NCT00486278

Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds

A Multi-centre, Randomised, Double-blinded, Controlled, Dose-escalation Trial on Safety and Efficacy of Activated Recombinant FVII Analogue (NN1731) in the Treatment of Joint Bleeds in Congenital Haemophilia Patients With Inhibitors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Africa, Asia, Europe, Japan, and North and South America. The aim of this trial is to evaluate the safety and efficacy of activated recombinant human factor VII analogue (vatreptocog alfa (activated)) in haemophilia patients with inhibitors.

Conditions

• Congenital Bleeding Disorder
• Haemophilia A
• Haemophilia B

Interventions

Type	Name	Description
DRUG	eptacog alfa (activated)	90 mcg/kg, injected i.v.
DRUG	vatreptacog alfa (activated)	5 mcg/kg, injected i.v.
DRUG	vatreptacog alfa (activated)	10 mcg/kg, injected i.v.
DRUG	vatreptacog alfa (activated)	20 mcg/kg, injected i.v.
DRUG	vatreptacog alfa (activated)	40 mcg/kg, injected i.v.
DRUG	vatreptacog alfa (activated)	80 mcg/kg, injected i.v.

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2007-06-14
• Last updated: 2017-03-07
• Results posted: 2014-12-25

Locations

45 sites across 18 countries: United States, Argentina, Brazil, Canada, Croatia, France, Hungary, Israel, Italy, Japan, Malaysia, Poland, South Africa, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom