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Recombinant Factor VIIa in Acute Intracerebral Haemorrhage (FAST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127283
First Posted: August 5, 2005
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
August 3, 2005
August 5, 2005
January 12, 2017
May 2005
January 2007   (Final data collection date for primary outcome measure)
Reducing disability and improving clinical outcome [ Time Frame: After 3 months ]
Reducing disability and improving clinical outcome
Complete list of historical versions of study NCT00127283 on ClinicalTrials.gov Archive Site
  • Reducing mortality
  • Reducing hematoma growth
  • Reducing hematoma growth
  • Reducing mortality
Not Provided
Not Provided
 
Recombinant Factor VIIa in Acute Intracerebral Haemorrhage
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Acquired Bleeding Disorder
  • Intracerebral Haemorrhage
Drug: eptacog alfa (activated)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
829
January 2007
January 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with secondary ICH
  • Pre-existing disability
  • Haemophilia
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Croatia,   Denmark,   Finland,   France,   Germany,   Hong Kong,   Israel,   Italy,   Netherlands,   Norway,   Singapore,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   United States
Argentina,   Mexico,   United Kingdom
 
NCT00127283
F7ICH-1641
2004-004202-24 ( EudraCT Number )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP