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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00123591
First received: June 30, 2005
Last updated: January 11, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Acquired Bleeding Disorder Trauma Drug: activated recombinant human factor VII Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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:
  • Evaluate the preliminary efficacy of Recombinant Activated Factor VII in preventing haemorrhagic progression in brain contusions

Enrollment: 96
Study Start Date: January 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123591

Locations
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
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00123591     History of Changes
Other Study ID Numbers: F7CBI-1600
2004-000088-92 ( EudraCT Number )
Study First Received: June 30, 2005
Last Updated: January 11, 2017

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on August 22, 2017