Acquired Bleeding Disorder Clinical Trial
— FASTOfficial 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
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.
| Status | Completed |
| Enrollment | 829 |
| Est. completion date | January 2007 |
| Est. primary completion date | January 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Spontaneous intracranial hemorrhage (ICH) within 3 hours after first symptom Exclusion Criteria: - Patients with secondary ICH - Pre-existing disability - Haemophilia |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Novo Nordisk Investigational Site | Camperdown | |
| Australia | Novo Nordisk Investigational Site | Gosford | |
| Australia | Novo Nordisk Investigational Site | Heidelberg Heights | |
| Australia | Novo Nordisk Investigational Site | Parkville | Victoria |
| Austria | Novo Nordisk Investigational Site | Graz | |
| Austria | Novo Nordisk Investigational Site | Innsbruck | |
| Belgium | Novo Nordisk Investigational Site | Antwerpen | |
| Belgium | Novo Nordisk Investigational Site | Brugge | |
| Belgium | Novo Nordisk Investigational Site | Brussels | |
| Belgium | Novo Nordisk Investigational Site | Brussels | |
| Brazil | Novo Nordisk Investigational Site | Sao Cristóvao | |
| Brazil | Novo Nordisk Investigational Site | Vila Clementino | |
| Canada | Novo Nordisk Investigational Site | Calgary | |
| Canada | Novo Nordisk Investigational Site | Edmonton | Alberta |
| Canada | Novo Nordisk Investigational Site | Greenfield Park | |
| Canada | Novo Nordisk Investigational Site | Halifax | Nova Scotia |
| Canada | Novo Nordisk Investigational Site | London | |
| Canada | Novo Nordisk Investigational Site | Mississauga | |
| Canada | Novo Nordisk Investigational Site | Montreal | |
| Canada | Novo Nordisk Investigational Site | Montreal | |
| Canada | Novo Nordisk Investigational Site | Ottawa | |
| Canada | Novo Nordisk Investigational Site | Quebec | |
| Canada | Novo Nordisk Investigational Site | Saint John | |
| Canada | Novo Nordisk Investigational Site | Saskatoon | |
| Canada | Novo Nordisk Investigational Site | Thunder Bay | |
| Canada | Novo Nordisk Investigational Site | Toronto | |
| Canada | Novo Nordisk Investigational Site | Vancouver | |
| China | Novo Nordisk Investigational Site | Beijing | Beijing |
| China | Novo Nordisk Investigational Site | Shanghai | Shanghai |
| China | Novo Nordisk Investigational Site | Shanghai | Shanghai |
| Croatia | Novo Nordisk Investigational Site | Zagreb | |
| Denmark | Novo Nordisk Investigational Site | Aalborg | |
| Denmark | Novo Nordisk Investigational Site | Århus | |
| Denmark | Novo Nordisk Investigational Site | Copenhagen | |
| Denmark | Novo Nordisk Investigational Site | Glostrup | |
| Finland | Novo Nordisk Investigational Site | Helsinki | |
| Finland | Novo Nordisk Investigational Site | Kuopio | |
| Finland | Novo Nordisk Investigational Site | Seinäjoki | |
| Finland | Novo Nordisk Investigational Site | Turku | |
| France | Novo Nordisk Investigational Site | Bordeaux | |
| France | Novo Nordisk Investigational Site | Paris | |
| France | Novo Nordisk Investigational Site | Paris | |
| France | Novo Nordisk Investigational Site | Paris | |
| France | Novo Nordisk Investigational Site | TOULOUSE cedex | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Germany | Novo Nordisk Investigational Site | Dresden | |
| Germany | Novo Nordisk Investigational Site | Essen | |
| Germany | Novo Nordisk Investigational Site | Heidelberg | |
| Germany | Novo Nordisk Investigational Site | Leipzig | |
| Germany | Novo Nordisk Investigational Site | Mannheim | |
| Germany | Novo Nordisk Investigational Site | Minden | |
| Germany | Novo Nordisk Investigational Site | München | |
| Germany | Novo Nordisk Investigational Site | Münster | |
| Hong Kong | Novo Nordisk Investigational Site | Hong Kong | |
| Israel | Novo Nordisk Investigational Site | Tel Aviv | |
| Israel | Novo Nordisk Investigational Site | Tel Hashomer | |
| Italy | Novo Nordisk Investigational Site | Firenze | |
| Italy | Novo Nordisk Investigational Site | Pavia | |
| Italy | Novo Nordisk Investigational Site | Perugia | |
| Italy | Novo Nordisk Investigational Site | Roma | |
| Netherlands | Novo Nordisk Investigational Site | Amsterdam | |
| Netherlands | Novo Nordisk Investigational Site | Amsterdam | |
| Netherlands | Novo Nordisk Investigational Site | Eindhoven | |
| Netherlands | Novo Nordisk Investigational Site | Heerlen | |
| Netherlands | Novo Nordisk Investigational Site | Rotterdam | |
| Netherlands | Novo Nordisk Investigational Site | Utrecht | |
| Norway | Novo Nordisk Investigational Site | Bergen | |
| Norway | Novo Nordisk Investigational Site | Kristiansand S | |
| Norway | Novo Nordisk Investigational Site | Nordbyhagen | |
| Norway | Novo Nordisk Investigational Site | Stavanger | |
| Norway | Novo Nordisk Investigational Site | Trondheim | |
| Singapore | Novo Nordisk Investigational Site | Singapore | |
| Singapore | Novo Nordisk Investigational Site | Singapore | |
| Spain | Novo Nordisk Investigational Site | Badalona | |
| Spain | Novo Nordisk Investigational Site | Barcelona | |
| Spain | Novo Nordisk Investigational Site | Barcelona | |
| Spain | Novo Nordisk Investigational Site | Girona | |
| Spain | Novo Nordisk Investigational Site | Madrid | |
| Sweden | Novo Nordisk Investigational Site | Linköping | |
| Sweden | Novo Nordisk Investigational Site | Malmö | |
| Sweden | Novo Nordisk Investigational Site | Stockholm | |
| Sweden | Novo Nordisk Investigational Site | Stockholm | |
| Sweden | Novo Nordisk Investigational Site | Stockholm | |
| Sweden | Novo Nordisk Investigational Site | Umeå | |
| Switzerland | Novo Nordisk Investigational Site | Lausanne | |
| Taiwan | Novo Nordisk Investigational Site | Taipei | |
| Taiwan | Novo Nordisk Investigational Site | Taipei | |
| Taiwan | Novo Nordisk Investigational Site | Taoyuan | |
| Thailand | Novo Nordisk Investigational Site | Bangkok | |
| Thailand | Novo Nordisk Investigational Site | Bangkok | |
| United States | Novo Nordisk Investigational Site | Allentown | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
| United States | Novo Nordisk Investigational Site | Augusta | Georgia |
| United States | Novo Nordisk Investigational Site | Baltimore | Maryland |
| United States | Novo Nordisk Investigational Site | Birmingham | Alabama |
| United States | Novo Nordisk Investigational Site | Boston | Massachusetts |
| United States | Novo Nordisk Investigational Site | Boston | Massachusetts |
| United States | Novo Nordisk Investigational Site | Boston | Massachusetts |
| United States | Novo Nordisk Investigational Site | Buffalo | New York |
| United States | Novo Nordisk Investigational Site | Burlington | Vermont |
| United States | Novo Nordisk Investigational Site | Chapel Hill | North Carolina |
| United States | Novo Nordisk Investigational Site | Charleston | South Carolina |
| United States | Novo Nordisk Investigational Site | Charlotte | North Carolina |
| United States | Novo Nordisk Investigational Site | Charlottesville | Virginia |
| United States | Novo Nordisk Investigational Site | Chattanooga | Tennessee |
| United States | Novo Nordisk Investigational Site | Cherry Hill | New Jersey |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Cincinnati | Ohio |
| United States | Novo Nordisk Investigational Site | Cleveland | Ohio |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Decatur | Georgia |
| United States | Novo Nordisk Investigational Site | Denver | Colorado |
| United States | Novo Nordisk Investigational Site | Denver | Colorado |
| United States | Novo Nordisk Investigational Site | Detroit | Michigan |
| United States | Novo Nordisk Investigational Site | Durham | North Carolina |
| United States | Novo Nordisk Investigational Site | Englewood | Colorado |
| United States | Novo Nordisk Investigational Site | Fort Smith | Arkansas |
| United States | Novo Nordisk Investigational Site | Fort Wayne | Indiana |
| United States | Novo Nordisk Investigational Site | Golden Valley | Minnesota |
| United States | Novo Nordisk Investigational Site | Hackensack | New Jersey |
| United States | Novo Nordisk Investigational Site | Hartford | Connecticut |
| United States | Novo Nordisk Investigational Site | Hashville | Tennessee |
| United States | Novo Nordisk Investigational Site | Honolulu | Hawaii |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Indianapolis | Indiana |
| United States | Novo Nordisk Investigational Site | Iowa City | Iowa |
| United States | Novo Nordisk Investigational Site | Jacksonville | Mississippi |
| United States | Novo Nordisk Investigational Site | Jacksonville | Florida |
| United States | Novo Nordisk Investigational Site | Kansas City | Missouri |
| United States | Novo Nordisk Investigational Site | Las Vegas | Nevada |
| United States | Novo Nordisk Investigational Site | Lebanon | New Hampshire |
| United States | Novo Nordisk Investigational Site | Lexington | Kentucky |
| United States | Novo Nordisk Investigational Site | Los Angeles | California |
| United States | Novo Nordisk Investigational Site | Louisville | Kentucky |
| United States | Novo Nordisk Investigational Site | Madison | Wisconsin |
| United States | Novo Nordisk Investigational Site | Maywood | Illinois |
| United States | Novo Nordisk Investigational Site | Melbourne | Florida |
| United States | Novo Nordisk Investigational Site | Memphis | Tennessee |
| United States | Novo Nordisk Investigational Site | Mobile | Alabama |
| United States | Novo Nordisk Investigational Site | Nashville | Tennessee |
| United States | Novo Nordisk Investigational Site | New York | New York |
| United States | Novo Nordisk Investigational Site | Oceanside | California |
| United States | Novo Nordisk Investigational Site | Orange | California |
| United States | Novo Nordisk Investigational Site | Peoria | Illinois |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Phoenix | Arizona |
| United States | Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Portland | Oregon |
| United States | Novo Nordisk Investigational Site | Portland | Oregon |
| United States | Novo Nordisk Investigational Site | Ridgewood | New Jersey |
| United States | Novo Nordisk Investigational Site | Sacramento | California |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | San Diego | California |
| United States | Novo Nordisk Investigational Site | San Francisco | California |
| United States | Novo Nordisk Investigational Site | San Francisco | California |
| United States | Novo Nordisk Investigational Site | Seattle | Washington |
| United States | Novo Nordisk Investigational Site | St. Louis | Missouri |
| United States | Novo Nordisk Investigational Site | St. Louis | Missouri |
| United States | Novo Nordisk Investigational Site | Stanford | California |
| United States | Novo Nordisk Investigational Site | Stony Brook | New York |
| United States | Novo Nordisk Investigational Site | Tallahassee | Florida |
| United States | Novo Nordisk Investigational Site | Tampa | Florida |
| United States | Novo Nordisk Investigational Site | Washington | District of Columbia |
| United States | Novo Nordisk Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Netherlands, Norway, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand,
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. — View 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: — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reducing disability and improving clinical outcome | After 3 months | No | |
| Secondary | Reducing mortality | No | ||
| Secondary | Reducing hematoma growth | No |
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