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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00426803
Registration number
NCT00426803
Ethics application status
Date submitted
24/01/2007
Date registered
25/01/2007
Date last updated
18/01/2017
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, Study to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (NovoSeven®) in Acute Intracerebral Haemorrhage
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Secondary ID [1]
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F7ICH-1371
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Universal Trial Number (UTN)
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Trial acronym
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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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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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Other neurological disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - activated recombinant human factor VII
Treatment: Drugs: activated recombinant human factor VII
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Intervention code [1]
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Treatment: Drugs
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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 haematoma growth
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Assessment method [1]
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Timepoint [1]
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Secondary 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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Eligibility
Key inclusion criteria
- Spontaneous intracranial haemorrhage (ICH) within 3 hours after first symptom
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Minimum age
18
Years
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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 2
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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
1/08/2002
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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
1/06/2004
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Sample size
Target
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Accrual to date
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Final
400
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Novo Nordisk Investigational Site - Melbourne
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Recruitment postcode(s) [1]
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VIC 3052 - Melbourne
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Graz
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Belgium
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State/province [2]
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Antwerpen
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Country [3]
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Canada
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State/province [3]
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Calgary
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Country [4]
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Denmark
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State/province [4]
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Aarhus
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Country [5]
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Finland
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State/province [5]
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Helsinki
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Country [6]
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Germany
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State/province [6]
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Leipzig
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Country [7]
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Italy
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State/province [7]
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Perugia
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Country [8]
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Netherlands
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State/province [8]
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Amsterdam
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Country [9]
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Norway
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State/province [9]
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Bergen
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Country [10]
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Singapore
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State/province [10]
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Singapore
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Country [11]
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Spain
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State/province [11]
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Madrid
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Country [12]
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Sweden
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State/province [12]
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Stockholm
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Country [13]
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Switzerland
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State/province [13]
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Lausanne
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Country [14]
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United Kingdom
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State/province [14]
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Newcastle Upon Tyne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novo Nordisk A/S
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This trial is conducted in North America, Europe, Asia and Oceania. The purpose of this study
is to evaluate safety and efficacy of Recombinant Factor VIIa in patients with acute
intracerebral bleeding.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00426803
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Global Clinical Registry (GCR, 1452)
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Address
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Novo Nordisk A/S
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00426803
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