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Recombinant Factor VIIa in Acute Intracerebral Haemorrhage — FAST  

Acquired Bleeding Disorder Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00127283
Study type Interventional
Source Novo Nordisk A/S
Contact
Status Completed
Phase Phase 3
Start date May 2005
Completion date January 2007
View Details
See also
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Completed NCT00123591 - Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Traumatic Brain Injury Phase 2
Completed NCT01562574 - Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease Phase 3
Completed NCT01285089 - Observational Study on the Use of NovoSeven® for Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia N/A
Terminated NCT00154427 - Use of Activated Recombinant Human Factor VII in Cardiac Surgery Phase 2
Completed NCT00426803 - Recombinant Factor VIIa in Acute Intracerebral Haemorrhage Phase 2