NCT00127283

Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

Randomised, Double-Blind, Placebo Controlled, Multi-Centre, Parallel Groups Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in Acute Intracerebral Haemorrhage

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 829 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Asia, Europe, Middle East, North America, Oceania, and South America. The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa (eptacog alfa (activated)) in patients with acute intracerebral bleeding. It is expected that more patients will recover without severe permanent disability after acute treatment with Recombinant Factor VIIa by reducing further intracerebral bleeding.

Conditions

• Acquired Bleeding Disorder
• Intracerebral Haemorrhage

Interventions

Type	Name	Description
DRUG	eptacog alfa (activated)

Timeline

• Start date: 2005-05-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2005-08-05
• Last updated: 2017-01-12

Locations

167 sites across 23 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Netherlands, Norway, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand