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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00127283
Registration number
NCT00127283
Ethics application status
Date submitted
3/08/2005
Date registered
5/08/2005
Date last updated
12/01/2017
Titles & IDs
Public title
Recombinant Factor VIIa in Acute Intracerebral Haemorrhage
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Scientific title
Randomised, Double-Blind, Placebo Controlled, Multi-Centre, Parallel Groups Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in Acute Intracerebral Haemorrhage
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Secondary ID [1]
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2004-004202-24
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Secondary ID [2]
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F7ICH-1641
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Universal Trial Number (UTN)
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Trial acronym
FAST
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acquired Bleeding Disorder
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0
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Intracerebral Haemorrhage
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Condition category
Condition code
Stroke
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Haemorrhagic
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Neurological
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0
0
0
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Other neurological disorders
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Cardiovascular
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0
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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0
0
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Reducing disability and improving clinical outcome
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Assessment method [1]
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Timepoint [1]
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After 3 months
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Secondary outcome [1]
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Reducing mortality
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Reducing hematoma growth
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Assessment method [2]
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Timepoint [2]
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Eligibility
Key inclusion criteria
* Spontaneous intracranial hemorrhage (ICH) within 3 hours after first symptom
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patients with secondary ICH
* Pre-existing disability
* Haemophilia
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2007
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Sample size
Target
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Accrual to date
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Final
829
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Novo Nordisk Investigational Site - Parkville
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Novo Nordisk Investigational Site - Camperdown
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Novo Nordisk Investigational Site - Gosford
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Novo Nordisk Investigational Site - Heidelberg Heights
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3052 - Parkville
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Recruitment postcode(s) [2]
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2050 - Camperdown
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2250 - Gosford
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Recruitment postcode(s) [4]
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3081 - Heidelberg Heights
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Recruitment outside Australia
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Funding & Sponsors
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Name
Novo Nordisk A/S
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Address
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Ethics approval
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Summary
Brief summary
This trial is conducted in Asia, Europe, Middle East, North America, Oceania, and South America. The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa (eptacog alfa (activated)) in patients with acute intracerebral bleeding. It is expected that more patients will recover without severe permanent disability after acute treatment with Recombinant Factor VIIa by reducing further intracerebral bleeding.
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Trial website
https://clinicaltrials.gov/study/NCT00127283
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Trial related presentations / publications
Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec. Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T; FAST Trial Investigators. Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2008 May 15;358(20):2127-37. doi: 10.1056/NEJMoa0707534.
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Public notes
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Contacts
Principal investigator
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Global Clinical Registry (GCR, 1452)
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Novo Nordisk A/S
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Hsia CC, Chin-Yee IH, McAlister VC. Use of recombi...
[
More Details
]
Journal
Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT00127283
Download to PDF