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NCT00123591 Clinical Trial

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

Trauma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00123591
Other study ID # F7CBI-1600
Secondary ID 2004-000088-92
Status Completed
Phase Phase 2
First received June 30, 2005
Last updated January 11, 2017
Start date January 2005
Est. completion date May 2006

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of HealthSpain: Spanish Agency of MedicinesSingapore: Health Sciences AuthorityCanada: Health CanadaFinland: Finnish Medicines AgencyItaly: Ministry of HealthGermany: Paul-Ehrlich-InstitutIsrael: Israeli Health Ministry Pharmaceutical AdministrationSwitzerland: SwissmedicIndia: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 96
Est. completion date May 2006
Est. primary completion date May 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• activated recombinant human factor VII

Locations
Country Name City State
Canada Novo Nordisk Investigational Site Montreal
Finland Novo Nordisk Investigational Site Helsinki
Germany Novo Nordisk Investigational Site Hannover
India Novo Nordisk Investigational Site Bangalore
India Novo Nordisk Investigational Site New Dehli New Delhi
Israel Novo Nordisk Investigational Site Haifa
Israel Novo Nordisk Investigational Site Ramat Gan
Israel Novo Nordisk Investigational Site Tel-Aviv
Italy Novo Nordisk Investigational Site Cesena
Netherlands Novo Nordisk Investigational Site Rotterdam
Singapore Novo Nordisk Investigational Site Singapore
Singapore Novo Nordisk Investigational Site Singapore
Spain Novo Nordisk Investigational Site Barcelona
Switzerland Novo Nordisk Investigational Site Zürich
Taiwan Novo Nordisk Investigational Site Taoyuan

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Canada,  Finland,  Germany,  India,  Israel,  Italy,  Netherlands,  Singapore,  Spain,  Switzerland,  Taiwan, 

References & Publications (1)

Narayan RK, Maas AI, Marshall LF, Servadei F, Skolnick BE, Tillinger MN; rFVIIa Traumatic ICH Study Group.. Recombinant factor VIIA in traumatic intracerebral hemorrhage: results of a dose-escalation clinical trial. Neurosurgery. 2008 Apr;62(4):776-86; di — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the Safety of Recombinant Activated Factor VII in Subjects with Brain Contusions Within the first 15 days of injury No
Secondary Evaluate the preliminary efficacy of Recombinant Activated Factor VII in preventing haemorrhagic progression in brain contusions No
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