NCT00123591

Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Traumatic Brain Injury

A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of Recombinant Factor VIIa (NovoSeven®/NiaStase®) in Subjects With Brain Contusions

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (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, and North America. The primary objective of the trial is to evaluate the safety of Recombinant Activated Factor VII in patients with brain contusions. The secondary objective of the trial is to evaluate the preliminary efficacy of Recombinant Activated Factor VII in preventing early haemorrhagic progression in contusive brain injury.

Conditions

• Acquired Bleeding Disorder
• Trauma

Interventions

Type	Name	Description
DRUG	activated recombinant human factor VII

Timeline

• Start date: 2005-01-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2005-07-25
• Last updated: 2017-01-12

Locations

15 sites across 11 countries: Canada, Finland, Germany, India, Israel, Italy, Netherlands, Singapore, Spain, Switzerland, Taiwan