Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Traumatic Brain Injury
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00123591
First received: June 30, 2005
Last updated: June 15, 2012
Last verified: January 2012
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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:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123591
Locations
| Canada | |
| Toronto, Canada | |
| Finland | |
| Helsinki, Finland | |
| Germany | |
| Ulm, Germany | |
| India | |
| New Delhi, India | |
| Israel | |
| Tel-Aviv, Israel | |
| Italy | |
| Cesena, Italy | |
| Netherlands | |
| Rotterdam, Netherlands | |
| Singapore | |
| Singapore, Singapore | |
| Spain | |
| Barcelona, Spain | |
| Switzerland | |
| Zürich, Switzerland | |
| Taiwan | |
| Taoyuan, Taiwan | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Michael Tillinger | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00123591 History of Changes |
| Other Study ID Numbers: | F7CBI-1600, 2004-000088-92 |
| Study First Received: | June 30, 2005 |
| Last Updated: | June 15, 2012 |
| 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 Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) 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 October 16, 2012
