Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Secondary ID [1] 0 0
2004-004202-24
Secondary ID [2] 0 0
F7ICH-1641
Universal Trial Number (UTN)
Trial acronym
FAST
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 disability and improving clinical outcome
Timepoint [1] 0 0
After 3 months
Secondary outcome [1] 0 0
Reducing mortality
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Reducing hematoma growth
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
* Spontaneous intracranial hemorrhage (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 3
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
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2007
Sample size
Target
Accrual to date
Final
829
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Parkville
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Camperdown
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Gosford
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Heidelberg Heights
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
3081 - Heidelberg Heights
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Hawaii
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Iowa
Country [14] 0 0
United States of America
State/province [14] 0 0
Kentucky
Country [15] 0 0
United States of America
State/province [15] 0 0
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Massachusetts
Country [17] 0 0
United States of America
State/province [17] 0 0
Michigan
Country [18] 0 0
United States of America
State/province [18] 0 0
Minnesota
Country [19] 0 0
United States of America
State/province [19] 0 0
Mississippi
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
Country [21] 0 0
United States of America
State/province [21] 0 0
Nevada
Country [22] 0 0
United States of America
State/province [22] 0 0
New Hampshire
Country [23] 0 0
United States of America
State/province [23] 0 0
New Jersey
Country [24] 0 0
United States of America
State/province [24] 0 0
New York
Country [25] 0 0
United States of America
State/province [25] 0 0
North Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Ohio
Country [27] 0 0
United States of America
State/province [27] 0 0
Oregon
Country [28] 0 0
United States of America
State/province [28] 0 0
Pennsylvania
Country [29] 0 0
United States of America
State/province [29] 0 0
South Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
Tennessee
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
Country [32] 0 0
United States of America
State/province [32] 0 0
Vermont
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Washington
Country [35] 0 0
United States of America
State/province [35] 0 0
Wisconsin
Country [36] 0 0
Austria
State/province [36] 0 0
Graz
Country [37] 0 0
Austria
State/province [37] 0 0
Innsbruck
Country [38] 0 0
Belgium
State/province [38] 0 0
Antwerpen
Country [39] 0 0
Belgium
State/province [39] 0 0
Brugge
Country [40] 0 0
Belgium
State/province [40] 0 0
Brussels
Country [41] 0 0
Brazil
State/province [41] 0 0
Sao Cristóvao
Country [42] 0 0
Brazil
State/province [42] 0 0
Vila Clementino
Country [43] 0 0
Canada
State/province [43] 0 0
Alberta
Country [44] 0 0
Canada
State/province [44] 0 0
Nova Scotia
Country [45] 0 0
Canada
State/province [45] 0 0
Calgary
Country [46] 0 0
Canada
State/province [46] 0 0
Greenfield Park
Country [47] 0 0
Canada
State/province [47] 0 0
London
Country [48] 0 0
Canada
State/province [48] 0 0
Mississauga
Country [49] 0 0
Canada
State/province [49] 0 0
Montreal
Country [50] 0 0
Canada
State/province [50] 0 0
Ottawa
Country [51] 0 0
Canada
State/province [51] 0 0
Quebec
Country [52] 0 0
Canada
State/province [52] 0 0
Saint John
Country [53] 0 0
Canada
State/province [53] 0 0
Saskatoon
Country [54] 0 0
Canada
State/province [54] 0 0
Thunder Bay
Country [55] 0 0
Canada
State/province [55] 0 0
Toronto
Country [56] 0 0
Canada
State/province [56] 0 0
Vancouver
Country [57] 0 0
China
State/province [57] 0 0
Beijing
Country [58] 0 0
China
State/province [58] 0 0
Shanghai
Country [59] 0 0
Croatia
State/province [59] 0 0
Zagreb
Country [60] 0 0
Denmark
State/province [60] 0 0
Aalborg
Country [61] 0 0
Denmark
State/province [61] 0 0
Copenhagen
Country [62] 0 0
Denmark
State/province [62] 0 0
Glostrup
Country [63] 0 0
Denmark
State/province [63] 0 0
Århus
Country [64] 0 0
Finland
State/province [64] 0 0
Helsinki
Country [65] 0 0
Finland
State/province [65] 0 0
Kuopio
Country [66] 0 0
Finland
State/province [66] 0 0
Seinäjoki
Country [67] 0 0
Finland
State/province [67] 0 0
Turku
Country [68] 0 0
France
State/province [68] 0 0
Bordeaux
Country [69] 0 0
France
State/province [69] 0 0
Paris
Country [70] 0 0
France
State/province [70] 0 0
TOULOUSE cedex
Country [71] 0 0
Germany
State/province [71] 0 0
Berlin
Country [72] 0 0
Germany
State/province [72] 0 0
Dresden
Country [73] 0 0
Germany
State/province [73] 0 0
Essen
Country [74] 0 0
Germany
State/province [74] 0 0
Heidelberg
Country [75] 0 0
Germany
State/province [75] 0 0
Leipzig
Country [76] 0 0
Germany
State/province [76] 0 0
Mannheim
Country [77] 0 0
Germany
State/province [77] 0 0
Minden
Country [78] 0 0
Germany
State/province [78] 0 0
München
Country [79] 0 0
Germany
State/province [79] 0 0
Münster
Country [80] 0 0
Hong Kong
State/province [80] 0 0
Hong Kong
Country [81] 0 0
Israel
State/province [81] 0 0
Tel Aviv
Country [82] 0 0
Israel
State/province [82] 0 0
Tel Hashomer
Country [83] 0 0
Italy
State/province [83] 0 0
Firenze
Country [84] 0 0
Italy
State/province [84] 0 0
Pavia
Country [85] 0 0
Italy
State/province [85] 0 0
Perugia
Country [86] 0 0
Italy
State/province [86] 0 0
Roma
Country [87] 0 0
Netherlands
State/province [87] 0 0
Amsterdam
Country [88] 0 0
Netherlands
State/province [88] 0 0
Eindhoven
Country [89] 0 0
Netherlands
State/province [89] 0 0
Heerlen
Country [90] 0 0
Netherlands
State/province [90] 0 0
Rotterdam
Country [91] 0 0
Netherlands
State/province [91] 0 0
Utrecht
Country [92] 0 0
Norway
State/province [92] 0 0
Bergen
Country [93] 0 0
Norway
State/province [93] 0 0
Kristiansand S
Country [94] 0 0
Norway
State/province [94] 0 0
Nordbyhagen
Country [95] 0 0
Norway
State/province [95] 0 0
Stavanger
Country [96] 0 0
Norway
State/province [96] 0 0
Trondheim
Country [97] 0 0
Singapore
State/province [97] 0 0
Singapore
Country [98] 0 0
Spain
State/province [98] 0 0
Badalona
Country [99] 0 0
Spain
State/province [99] 0 0
Barcelona
Country [100] 0 0
Spain
State/province [100] 0 0
Girona
Country [101] 0 0
Spain
State/province [101] 0 0
Madrid
Country [102] 0 0
Sweden
State/province [102] 0 0
Linköping
Country [103] 0 0
Sweden
State/province [103] 0 0
Malmö
Country [104] 0 0
Sweden
State/province [104] 0 0
Stockholm
Country [105] 0 0
Sweden
State/province [105] 0 0
Umeå
Country [106] 0 0
Switzerland
State/province [106] 0 0
Lausanne
Country [107] 0 0
Taiwan
State/province [107] 0 0
Taipei
Country [108] 0 0
Taiwan
State/province [108] 0 0
Taoyuan
Country [109] 0 0
Thailand
State/province [109] 0 0
Bangkok

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/NCT00127283