NCT00571584

High Dose of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors

rFVIIa (NovoSeven®) for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors: A Double-blind Study of a Single High Dose Versus Standard Multiple Doses of rFVIIa

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor VII in treatment of joint bleeds in haemophilia patients with inhibitors.

Conditions

• Congenital Bleeding Disorder
• Haemophilia A With Inhibitors
• Haemophilia B With Inhibitors

Interventions

Type	Name	Description
DRUG	activated recombinant human factor VII

Timeline

• Start date: 2002-11-01
• Primary completion: 2004-03-01
• Completion: 2004-03-01
• First posted: 2007-12-12
• Last updated: 2017-01-12

Locations

18 sites across 7 countries: France, Hungary, Israel, Poland, Spain, Turkey (Türkiye), United Kingdom