Factor VIIa in Acute Intracerebral Haemorrhage

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


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

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
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: NCT00266006

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

Additional Information:
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
Cerebral Hemorrhage
Hemorrhage
Hemostatic Disorders
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Hematologic Diseases
Hemorrhagic Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014