Clinical trial NCT00127283: Recombinant Factor VIIa in Acute Intracerebral Haemorrhage
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acquired Bleeding Disorder
Intracerebral Haemorrhage
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-08-05
Enrollment: 829
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Spontaneous intracranial hemorrhage (ICH) within 3 hours after first symptom

Exclusion Criteria:

* Patients with secondary ICH
* Pre-existing disability
* Haemophilia

Primary outcomes:
measure: Reducing disability and improving clinical outcome
timeFrame: After 3 months
Secondary outcomes:
measure: Reducing mortality
measure: Reducing hematoma growth
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Fort Smith
country: United States
facility: Novo Nordisk Investigational Site
state: Arkansas
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Oceanside
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Orange
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Sacramento
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Diego
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Francisco
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Francisco
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Stanford
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Denver
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Denver
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Englewood
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Hartford
country: United States
facility: Novo Nordisk Investigational Site
state: Connecticut
city: Washington
country: United States
facility: Novo Nordisk Investigational Site
state: District of Columbia
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Tampa
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Augusta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Novo Nordisk Investigational Site
state: Hawaii
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Maywood
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Fort Wayne
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Iowa City
country: United States
facility: Novo Nordisk Investigational Site
state: Iowa
city: Lexington
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Boston
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Golden Valley
country: United States
facility: Novo Nordisk Investigational Site
state: Minnesota
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Mississippi
city: Kansas City
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Lebanon
country: United States
facility: Novo Nordisk Investigational Site
state: New Hampshire
city: Cherry Hill
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Hackensack
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Ridgewood
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Buffalo
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: New York
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Stony Brook
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Durham
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Portland
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Portland
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Allentown
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Hashville
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Burlington
country: United States
facility: Novo Nordisk Investigational Site
state: Vermont
city: Charlottesville
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Madison
country: United States
facility: Novo Nordisk Investigational Site
state: Wisconsin
city: Parkville
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Camperdown
country: Australia
facility: Novo Nordisk Investigational Site
city: Gosford
country: Australia
facility: Novo Nordisk Investigational Site
city: Heidelberg Heights
country: Australia
facility: Novo Nordisk Investigational Site
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
city: Innsbruck
country: Austria
facility: Novo Nordisk Investigational Site
city: Antwerpen
country: Belgium
facility: Novo Nordisk Investigational Site
city: Brugge
country: Belgium
facility: Novo Nordisk Investigational Site
city: Brussels
country: Belgium
facility: Novo Nordisk Investigational Site
city: Brussels
country: Belgium
facility: Novo Nordisk Investigational Site
city: Sao Cristóvao
country: Brazil
facility: Novo Nordisk Investigational Site
city: Vila Clementino
country: Brazil
facility: Novo Nordisk Investigational Site
city: Edmonton
country: Canada
facility: Novo Nordisk Investigational Site
state: Alberta
city: Halifax
country: Canada
facility: Novo Nordisk Investigational Site
state: Nova Scotia
city: Calgary
country: Canada
facility: Novo Nordisk Investigational Site
city: Greenfield Park
country: Canada
facility: Novo Nordisk Investigational Site
city: London
country: Canada
facility: Novo Nordisk Investigational Site
city: Mississauga
country: Canada
facility: Novo Nordisk Investigational Site
city: Montreal
country: Canada
facility: Novo Nordisk Investigational Site
city: Montreal
country: Canada
facility: Novo Nordisk Investigational Site
city: Ottawa
country: Canada
facility: Novo Nordisk Investigational Site
city: Quebec
country: Canada
facility: Novo Nordisk Investigational Site
city: Saint John
country: Canada
facility: Novo Nordisk Investigational Site
city: Saskatoon
country: Canada
facility: Novo Nordisk Investigational Site
city: Thunder Bay
country: Canada
facility: Novo Nordisk Investigational Site
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
city: Vancouver
country: Canada
facility: Novo Nordisk Investigational Site
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Zagreb
country: Croatia
facility: Novo Nordisk Investigational Site
city: Aalborg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Copenhagen
country: Denmark
facility: Novo Nordisk Investigational Site
city: Glostrup
country: Denmark
facility: Novo Nordisk Investigational Site
city: Århus
country: Denmark
facility: Novo Nordisk Investigational Site
city: Helsinki
country: Finland
facility: Novo Nordisk Investigational Site
city: Kuopio
country: Finland
facility: Novo Nordisk Investigational Site
city: Seinäjoki
country: Finland
facility: Novo Nordisk Investigational Site
city: Turku
country: Finland
facility: Novo Nordisk Investigational Site
city: Bordeaux
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: TOULOUSE cedex
country: France
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Dresden
country: Germany
facility: Novo Nordisk Investigational Site
city: Essen
country: Germany
facility: Novo Nordisk Investigational Site
city: Heidelberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Leipzig
country: Germany
facility: Novo Nordisk Investigational Site
city: Mannheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Minden
country: Germany
facility: Novo Nordisk Investigational Site
city: München
country: Germany
facility: Novo Nordisk Investigational Site
city: Münster
country: Germany
facility: Novo Nordisk Investigational Site
city: Hong Kong
country: Hong Kong
facility: Novo Nordisk Investigational Site
city: Tel Aviv
country: Israel
facility: Novo Nordisk Investigational Site
city: Tel Hashomer
country: Israel
facility: Novo Nordisk Investigational Site
city: Firenze
country: Italy
facility: Novo Nordisk Investigational Site
city: Pavia
country: Italy
facility: Novo Nordisk Investigational Site
city: Perugia
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Amsterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Amsterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Eindhoven
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Heerlen
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Rotterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Utrecht
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Bergen
country: Norway
facility: Novo Nordisk Investigational Site
city: Kristiansand S
country: Norway
facility: Novo Nordisk Investigational Site
city: Nordbyhagen
country: Norway
facility: Novo Nordisk Investigational Site
city: Stavanger
country: Norway
facility: Novo Nordisk Investigational Site
city: Trondheim
country: Norway
facility: Novo Nordisk Investigational Site
city: Singapore
country: Singapore
facility: Novo Nordisk Investigational Site
city: Singapore
country: Singapore
facility: Novo Nordisk Investigational Site
city: Badalona
country: Spain
facility: Novo Nordisk Investigational Site
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Girona
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Linköping
country: Sweden
facility: Novo Nordisk Investigational Site
city: Malmö
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Umeå
country: Sweden
facility: Novo Nordisk Investigational Site
city: Lausanne
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Taipei
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Taipei
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Taoyuan
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.