NCT00184548

Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding

A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/NiaStase®) in Severely Injured Trauma Patients With Bleeding Refractory to Standard Treatment

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 554 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted globally. The purpose of the trial is to evaluate that activated recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely injured trauma patients by assessing mortality and morbidity. Please note that this trial and trial F7TRAUMA-1648 (NCT00323570) have been merged.

Detailed description

The decision to discontinue the F7TRAUMA-1711 trial is not due to any safety concerns. The result of the pre-planned futility analysis performed in June 2008 predicted a very low likelihood of reaching a successful outcome on the primary efficacy endpoint at the end of the trial and as a consequence, the company has decided to close the trial as this juncture.

Conditions

• Acquired Bleeding Disorder
• Trauma

Interventions

Type	Name	Description
DRUG	eptacog alfa (activated)	Sterile, freeze-dried powder in single-use vials to be reconstituted with sterile water for injection. Three doses of 200, 100 and 100 mcg/kg to be administered bolus i.v. (intravenous) over approx. three hours.
DRUG	placebo	placebo

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2005-09-16
• Last updated: 2014-06-25
• Results posted: 2009-11-26

Locations

14 sites across 14 countries: United States, Brazil, Czechia, France, Germany, Greece, Hong Kong, Hungary, Italy, Netherlands, South Africa, Spain, Switzerland, United Kingdom