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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00123591
First received: June 30, 2005
Last updated: October 23, 2013
Last verified: October 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the preliminary efficacy of Recombinant Activated Factor VII in preventing haemorrhagic progression in brain contusions [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
Montreal, Canada, H3G 1A4
Finland
Helsinki, Finland, 00250
Germany
Hannover, Germany, 30625
India
New Dehli, New Delhi, India, 110029
Israel
Tel-Aviv, Israel, 64239
Italy
Cesena, Italy, 47023
Singapore
Singapore, Singapore, 308443
Spain
Barcelona, Spain, 08035
Switzerland
Zürich, Switzerland, 8091
Taiwan
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Michael Tillinger Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00123591     History of Changes
Other Study ID Numbers: F7CBI-1600, 2004-000088-92
Study First Received: June 30, 2005
Last Updated: October 23, 2013
Health Authority: Taiwan: Department of Health
Spain: Spanish Agency of Medicines
Singapore: Health Sciences Authority
Canada: Health Canada
Finland: Finnish Medicines Agency
Italy: Ministry of Health
Germany: Paul-Ehrlich-Institut
Israel: Israeli Health Ministry Pharmaceutical Administration
Switzerland: Swissmedic
India: Ministry of Health

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemorrhage
Brain Injuries
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 14, 2014