Use of Activated Recombinant Human Factor VII in Cardiac Surgery

Acquired Bleeding Disorder Clinical Trial

Official title:

A Multi-centre, Randomised, Double-blind, Placebocontrolled, Dose Escalation Trial on Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Post-operative Bleeding in Patients Following Cardiac Surgery Requiring Cardiopulmonary Bypass

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00154427
• Other study ID #: F7CARD-1610
• Secondary ID: 2004-000100-40
• Status: Terminated
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: January 11, 2017
• Start date: August 2004
• Est. completion date: November 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)Spain: Spanish Agency of MedicinesSingapore: Health Sciences AuthorityDenmark: Danish Medicines AgencySouth Africa: Medicines Control CouncilGermany: Paul-Ehrlich-InstitutArgentina: Administracion Nacional de Medicamentos, Alimentos y TecnologiaBrazil: National Health Surveillance AgencyItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthSweden: Medical Products AgencyIndia: Ministry of HealthUnited States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyMalaysia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA).

The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in patients following cardiac surgery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 172
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Post-operative bleeding according to pre-defined criteria for critical bleeding

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
• Cardiac Surgery Requiring Cardiopulmonary Bypass
• Hemorrhage
• Hemostatic Disorders

Intervention

Drug:
• activated recombinant human factor VII

Locations

Country	Name	City	State
Argentina	Novo Nordisk Investigational Site	Buenos Aires
Argentina	Novo Nordisk Investigational Site	Caba
Argentina	Novo Nordisk Investigational Site	Capital Federal
Argentina	Novo Nordisk Investigational Site	Corrientes
Argentina	Novo Nordisk Investigational Site	Rosario
Brazil	Novo Nordisk Investigational Site	São Paulo
Denmark	Novo Nordisk Investigational Site	København ø
France	Novo Nordisk Investigational Site	NANTES Cedex 1
France	Novo Nordisk Investigational Site	Vandoeuvre Les Nancy
Germany	Novo Nordisk Investigational Site	Aachen
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Frankfurt/M.
Germany	Novo Nordisk Investigational Site	Köln
Germany	Novo Nordisk Investigational Site	Krefeld
Germany	Novo Nordisk Investigational Site	Leipzig
Germany	Novo Nordisk Investigational Site	München
Germany	Novo Nordisk Investigational Site	Ulm
India	Novo Nordisk Investigational Site	Bangalore
India	Novo Nordisk Investigational Site	Chennai
India	Novo Nordisk Investigational Site	Chennai
India	Novo Nordisk Investigational Site	New Delhi
India	Novo Nordisk Investigational Site	Trivendrum
Italy	Novo Nordisk Investigational Site	Bologna
Italy	Novo Nordisk Investigational Site	Milano
Italy	Novo Nordisk Investigational Site	Roma
Italy	Novo Nordisk Investigational Site	Roma
Italy	Novo Nordisk Investigational Site	San Donato Milanese (MI)
Malaysia	Novo Nordisk Investigational Site	Kuala Lumpur
Singapore	Novo Nordisk Investigational Site	Singapore
South Africa	Novo Nordisk Investigational Site	Cape Town	Western Cape
South Africa	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal
South Africa	Novo Nordisk Investigational Site	Johannesburg	Gauteng
Spain	Novo Nordisk Investigational Site	Barcelona
Spain	Novo Nordisk Investigational Site	Bilbao
Spain	Novo Nordisk Investigational Site	Madrid
Spain	Novo Nordisk Investigational Site	Madrid
Spain	Novo Nordisk Investigational Site	Madrid
Spain	Novo Nordisk Investigational Site	Sevilla
Sweden	Novo Nordisk Investigational Site	Lund
United Kingdom	Novo Nordisk Investigational Site	Cambridge
United Kingdom	Novo Nordisk Investigational Site	Leicester
United Kingdom	Novo Nordisk Investigational Site	London
United Kingdom	Novo Nordisk Investigational Site	London
United Kingdom	Novo Nordisk Investigational Site	London
United Kingdom	Novo Nordisk Investigational Site	Southampton
United States	Novo Nordisk Investigational Site	Atlanta	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	Bronx	New York
United States	Novo Nordisk Investigational Site	Bronx	New York
United States	Novo Nordisk Investigational Site	Camden	New Jersey
United States	Novo Nordisk Investigational Site	Cleveland	Ohio
United States	Novo Nordisk Investigational Site	Danville	Pennsylvania
United States	Novo Nordisk Investigational Site	Denver	Colorado
United States	Novo Nordisk Investigational Site	Houston	Texas
United States	Novo Nordisk Investigational Site	Norfolk	Virginia
United States	Novo Nordisk Investigational Site	Oklahoma City	Oklahoma
United States	Novo Nordisk Investigational Site	Portland	Oregon
United States	Novo Nordisk Investigational Site	Richmond	Virginia
United States	Novo Nordisk Investigational Site	San Francisco	California
United States	Novo Nordisk Investigational Site	Syracuse	New York
United States	Novo Nordisk Investigational Site	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Denmark,  France,  Germany,  India,  Italy,  Malaysia,  Singapore,  South Africa,  Spain,  Sweden,  United Kingdom, 

References & Publications (1)

Gill R, Herbertson M, Vuylsteke A, Olsen PS, von Heymann C, Mythen M, Sellke F, Booth F, Schmidt TA. Safety and efficacy of recombinant activated factor VII: a randomized placebo-controlled trial in the setting of bleeding after cardiac surgery. Circulati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of critical, serious adverse events		Within 30 days	No
Secondary	Surgical drainage volume		For the duration of the trial	No
Secondary	Amount of transfusions		For the duration of the trial	No

External Links

•   Clinical Trials at Novo Nordisk