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Factor VIIa in Acute Intracerebral Haemorrhage

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00266006
First received: December 14, 2005
Last updated: June 26, 2012
Last verified: September 2011
History of Changes
  Purpose

This trial is conducted in Japan. The purpose of this trial is to evaluate the safety and preliminary efficacy of Activated Recombinant Factor VII (NN-007) in patients with acute intracerebral haemorrhage.


Condition Intervention Phase
Acquired Bleeding Disorder
Intracerebral Haemorrhage
 Drug: activated recombinant human factor VII
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety of Eptacog Alfa (Activated) (Genetical Recombination) on Adverse Events and Serious Adverse Events in Patients With Acute Intracerebral Haemorrhage.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • The Occurrence of thromboembolic serious adverse event [ Time Frame: Until 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reducing disability and improving clinical outcome [ Designated as safety issue: No ]
  • Reducing haematoma growth [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: January 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Spontaneous ICH

Exclusion Criteria:

  • Time of ICH onset > 3 hours
  • Patients with secondary ICH
  • Pre-existing disability
  • Hemophilia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266006

Locations
Japan
Morioka, Japan
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Morio Arai, MD, PhD Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00266006     History of Changes
Other Study ID Numbers: F7ICH-1602, JapicCTI-050194
Study First Received: December 14, 2005
Last Updated: June 26, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemorrhage
Cerebral Hemorrhage
Hematologic Diseases
Vascular Diseases
 Cardiovascular Diseases
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013