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Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00426803
First Posted: January 25, 2007
Last Update Posted: January 18, 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
January 24, 2007
January 25, 2007
January 18, 2017
August 2002
June 2004   (Final data collection date for primary outcome measure)
Reducing haematoma growth
Same as current
Complete list of historical versions of study NCT00426803 on ClinicalTrials.gov Archive Site
Reducing disability and improving clinical outcome
Reducing disability and improving clinical outcome after 3 months
Not Provided
Not Provided
 
Recombinant Factor VIIa in Acute Intracerebral Haemorrhage
Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Parallel Groups, Study to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (NovoSeven®) in Acute Intracerebral Haemorrhage
This trial is conducted in North America, Europe, Asia and Oceania. The purpose of this study is to evaluate safety and efficacy of Recombinant Factor VIIa in patients with acute intracerebral bleeding.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Acquired Bleeding Disorder
  • Intracerebral Haemorrhage
Drug: activated recombinant human factor VII
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
June 2004
June 2004   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Spontaneous intracranial haemorrhage (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,   Canada,   Denmark,   Finland,   Germany,   Italy,   Netherlands,   Norway,   Singapore,   Spain,   Sweden,   Switzerland,   United Kingdom
Croatia,   Malaysia,   New Zealand,   Taiwan,   United States
 
NCT00426803
F7ICH-1371
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