Recombinant Factor VIIa in Acute Intracerebral Haemorrhage



Status:Completed
Conditions:Neurology, Hematology
Therapuetic Areas:Hematology, Neurology
Healthy:No
Age Range:18 - Any
Updated:1/13/2017
Start Date:May 2005
End Date:January 2007

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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

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.


Inclusion Criteria:

- Spontaneous intracranial hemorrhage (ICH) within 3 hours after first symptom

Exclusion Criteria:

- Patients with secondary ICH

- Pre-existing disability

- Haemophilia
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Honolulu, Hawaii 96814
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Allentown, Pennsylvania 18103
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