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Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Traumatic Brain Injury

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: NCT00123591
Recruitment Status : Completed
First Posted : July 25, 2005
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Asia, Europe, Middle East, and North America. The primary objective of the trial is to evaluate the safety of Recombinant Activated Factor VII in patients with brain contusions. The secondary objective of the trial is to evaluate the preliminary efficacy of Recombinant Activated Factor VII in preventing early haemorrhagic progression in contusive brain injury.

Condition or disease Intervention/treatment Phase
Acquired Bleeding Disorder Trauma Drug: activated recombinant human factor VII Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of Recombinant Factor VIIa (NovoSeven®/NiaStase®) in Subjects With Brain Contusions
Study Start Date : January 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bruises




Primary Outcome Measures :
  1. Evaluate the Safety of Recombinant Activated Factor VII in Subjects with Brain Contusions [ Time Frame: Within the first 15 days of injury ]

Secondary Outcome Measures :
  1. Evaluate the preliminary efficacy of Recombinant Activated Factor VII in preventing haemorrhagic progression in brain contusions


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Contusive brain injury (including brain stem) diagnosed by history, clinical examination and confirmed by CT scan within 6 hours of onset
  • In British Columbia and Nova Scotia, subjects must be = 19 years.

Information from the National Library of Medicine

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): NCT00123591


Locations
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Canada
Novo Nordisk Investigational Site
Montreal, Canada, H3G 1A4
Finland
Novo Nordisk Investigational Site
Helsinki, Finland, 00250
Germany
Novo Nordisk Investigational Site
Hannover, Germany, 30625
India
Novo Nordisk Investigational Site
New Dehli, New Delhi, India, 110029
Novo Nordisk Investigational Site
Bangalore, India, 560017
Israel
Novo Nordisk Investigational Site
Haifa, Israel, 31096
Novo Nordisk Investigational Site
Ramat Gan, Israel, 52621
Novo Nordisk Investigational Site
Tel-Aviv, Israel, 64239
Italy
Novo Nordisk Investigational Site
Cesena, Italy, 47023
Netherlands
Novo Nordisk Investigational Site
Rotterdam, Netherlands, 3015 GD
Singapore
Novo Nordisk Investigational Site
Singapore, Singapore, 119074
Novo Nordisk Investigational Site
Singapore, Singapore, 308443
Spain
Novo Nordisk Investigational Site
Barcelona, Spain, 08035
Switzerland
Novo Nordisk Investigational Site
Zürich, Switzerland, 8091
Taiwan
Novo Nordisk Investigational Site
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00123591    
Other Study ID Numbers: F7CBI-1600
2004-000088-92 ( EudraCT Number )
First Posted: July 25, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders