Recombinant Factor VIIa in Acute Intracerebral Haemorrhage (FAST)
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|ClinicalTrials.gov Identifier: NCT00127283|
Recruitment Status : Completed
First Posted : August 5, 2005
Last Update Posted : January 12, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Acquired Bleeding Disorder Intracerebral Haemorrhage||Drug: eptacog alfa (activated)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||829 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||January 2007|
- Reducing disability and improving clinical outcome [ Time Frame: After 3 months ]
- Reducing mortality
- Reducing hematoma growth
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127283
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|