drugset / Trial / NCT00127283

Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

NCT00127283

Phase 3 Completed 829 enrolled Novo Nordisk A/S
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2005-05
Primary completion
2007-01
Completion
2007-01

Drugs

EvaluationDrugModalityDoseRoute
Subject eptacog alfa (activated) Protein / enzyme biologic 20 ug/kg
Subject eptacog alfa (activated) Protein / enzyme biologic 80 ug/kg