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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
F7ICH-1371
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Bleeding Disorder 0 0
Intracerebral Haemorrhage 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reducing haematoma growth
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Reducing disability and improving clinical outcome
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Spontaneous intracranial haemorrhage (ICH) within 3 hours after first symptom
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with secondary ICH
* Pre-existing disability
* Haemophilia

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2004
Sample size
Target
Accrual to date
Final
400
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
VIC 3052 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Belgium
State/province [2] 0 0
Antwerpen
Country [3] 0 0
Canada
State/province [3] 0 0
Calgary
Country [4] 0 0
Denmark
State/province [4] 0 0
Aarhus
Country [5] 0 0
Finland
State/province [5] 0 0
Helsinki
Country [6] 0 0
Germany
State/province [6] 0 0
Leipzig
Country [7] 0 0
Italy
State/province [7] 0 0
Perugia
Country [8] 0 0
Netherlands
State/province [8] 0 0
Amsterdam
Country [9] 0 0
Norway
State/province [9] 0 0
Bergen
Country [10] 0 0
Singapore
State/province [10] 0 0
Singapore
Country [11] 0 0
Spain
State/province [11] 0 0
Madrid
Country [12] 0 0
Sweden
State/province [12] 0 0
Stockholm
Country [13] 0 0
Switzerland
State/province [13] 0 0
Lausanne
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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


Results not provided in https://clinicaltrials.gov/study/NCT00426803