Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

Acquired Bleeding Disorder Clinical Trial

— FAST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00127283
• Other study ID #: F7ICH-1641
• Secondary ID: 2004-004202-24
• Status: Completed
• Phase: Phase 3
• First received: August 3, 2005
• Last updated: January 11, 2017
• Start date: May 2005
• Est. completion date: January 2007

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Taiwan: Department of HealthSpain: Spanish Agency of MedicinesSingapore: Health Sciences AuthorityCroatia: Ministry of Health and Social CareDenmark: Danish Medicines AgencyBrazil: National Health Surveillance AgencyCanada: Health CanadaFinland: Finnish Medicines AgencyNetherlands: Dutch Health Care InspectorateAustria: Federal Ministry for Health and WomenGermany: Paul-Ehrlich-InstitutChina: Food and Drug AdministrationIsrael: Israeli Health Ministry Pharmaceutical AdministrationItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthAustralia: Department of Health and Ageing Therapeutic Goods AdministrationNorway: Norwegian Medicines AgencyThailand: Khon Kaen University Ethics Committee for Human ResearchSweden: Medical Products AgencyUnited States: Food and Drug AdministrationHong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Bleeding Disorder
• Blood Coagulation Disorders
• Cerebral Hemorrhage
• Hemorrhage
• Hemostatic Disorders
• Intracerebral Haemorrhage

Intervention

Drug:
• eptacog alfa (activated)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

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, 

References & Publications (2)

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

Outcome

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

External Links

•   Clinical Trials at Novo Nordisk