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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


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
See also
  Status Clinical Trial Phase
Completed NCT01601457 - Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction Phase 2
Completed NCT00124293 - Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety Issues After Traumatic Brain Injury N/A
Terminated NCT00184548 - Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Phase 3
Completed NCT02239146 - Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass Phase 1
Completed NCT01563445 - Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage Phase 2
Withdrawn NCT00323570 - Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma Phase 3
Completed NCT01563523 - Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma Patients Phase 2
Terminated NCT01564563 - Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation Phase 2
Completed NCT01153997 - Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese Volunteers Phase 1
Completed NCT00697320 - Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany N/A
Completed NCT00914589 - Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery Phase 2
Completed NCT00102037 - Use of Activated Recombinant FVII in Spinal Surgery Phase 2
Completed NCT01562821 - Safety and Efficacy of Activated Recombinant Human Factor VII in Cirrhotic Patients Undergoing Partial Hepatectomy Phase 2
Completed NCT01601613 - Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever Phase 2
Completed NCT00266006 - Factor VIIa in Acute Intracerebral Haemorrhage Phase 2
Completed NCT00123591 - Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Traumatic Brain Injury Phase 2
Completed NCT01562574 - Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease Phase 3
Completed NCT01285089 - Observational Study on the Use of NovoSeven® for Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia N/A
Terminated NCT00154427 - Use of Activated Recombinant Human Factor VII in Cardiac Surgery Phase 2
Completed NCT00426803 - Recombinant Factor VIIa in Acute Intracerebral Haemorrhage Phase 2