Back to resultsFactor VIIa in Acute Intracerebral Haemorrhage
Primary Purpose
Acquired Bleeding Disorder, Intracerebral Haemorrhage
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
eptacog alfa (activated)
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Bleeding Disorder
Eligibility Criteria
Inclusion Criteria: Spontaneous ICH Exclusion Criteria: Time of ICH onset > 3 hours Patients with secondary ICH Pre-existing disability Hemophilia
Sites / Locations
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
The Occurrence of thromboembolic serious adverse event
Secondary Outcome Measures
Reducing disability and improving clinical outcome
Reducing haematoma growth
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00266006
Brief Title
Factor VIIa in Acute Intracerebral Haemorrhage
Official Title
Safety of Eptacog Alfa (Activated) (Genetical Recombination) on Adverse Events and Serious Adverse Events in Patients With Acute Intracerebral Haemorrhage.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Bleeding Disorder, Intracerebral Haemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
eptacog alfa (activated)
Other Intervention Name(s)
activated recombinant human factor VII
Primary Outcome Measure Information:
Title
The Occurrence of thromboembolic serious adverse event
Time Frame
Until 90 days
Secondary Outcome Measure Information:
Title
Reducing disability and improving clinical outcome
Title
Reducing haematoma growth
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Spontaneous ICH
Exclusion Criteria:
Time of ICH onset > 3 hours
Patients with secondary ICH
Pre-existing disability
Hemophilia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
1000005
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Factor VIIa in Acute Intracerebral Haemorrhage
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