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Recombinant Factor VIIa in Acute Intracerebral Haemorrhage (FAST)

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.
 
ClinicalTrials.gov Identifier: NCT00127283
Recruitment Status : Completed
First Posted : August 5, 2005
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE August 3, 2005
First Posted Date  ICMJE August 5, 2005
Last Update Posted Date January 12, 2017
Study Start Date  ICMJE May 2005
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2007)
Reducing disability and improving clinical outcome [ Time Frame: After 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 3, 2005)
Reducing disability and improving clinical outcome
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2006)
  • Reducing mortality
  • Reducing hematoma growth
Original Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2005)
  • Reducing hematoma growth
  • Reducing mortality
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Recombinant Factor VIIa in Acute Intracerebral Haemorrhage
Official Title  ICMJE 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
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Acquired Bleeding Disorder
  • Intracerebral Haemorrhage
Intervention  ICMJE Drug: eptacog alfa (activated)
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2011)
829
Original Enrollment  ICMJE
 (submitted: August 3, 2005)
675
Actual Study Completion Date  ICMJE January 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with secondary ICH
  • Pre-existing disability
  • Haemophilia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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
Removed Location Countries Argentina,   Mexico,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00127283
Other Study ID Numbers  ICMJE F7ICH-1641
2004-004202-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date January 2017

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