drugset / Trial / NCT00184548

Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding

NCT00184548

Phase 3 Terminated 554 enrolled Novo Nordisk A/S
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2005-10
Primary completion
2008-09
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Subject eptacog alfa (activated) Protein / enzyme biologic 100 ug/kg Intravenous

Indications