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Factor VIIa in Acute Intracerebral Haemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00266006
Recruitment Status : Completed
First Posted : December 15, 2005
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Acquired Bleeding Disorder Intracerebral Haemorrhage Drug: eptacog alfa (activated) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, 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.
Study Start Date : January 2006
Primary Completion Date : April 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources


Intervention Details:
    Drug: eptacog alfa (activated)
    Other Name: activated recombinant human factor VII


Primary Outcome Measures :
  1. The Occurrence of thromboembolic serious adverse event [ Time Frame: Until 90 days ]

Secondary Outcome Measures :
  1. Reducing disability and improving clinical outcome
  2. Reducing haematoma growth


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00266006


Locations
Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00266006     History of Changes
Other Study ID Numbers: F7ICH-1602
JapicCTI-050194 ( Registry Identifier: japic )
First Posted: December 15, 2005    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

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