Trials Sponsors Conditions Drugs Pricing

NCT00154427

TerminatedPhase 2

Use of Activated Recombinant Human Factor VII in Cardiac Sur...

Novo Nordisk A/S Source

NCT00154427|TerminatedPhase 2

Study Stopped

Trial terminated after recruiting 172 patients but without proceeding to the highest dosing cohort as this no longer reflects common clinical practice

Use of Activated Recombinant Human Factor VII in Cardiac Surgery

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

Novo Nordisk A/S ClinicalTrials.gov

2 other identifiers

F7CARD-16102004-000100-40

Study Type

interventional

Target

172

Locations

14 countries

Sites

63

Timeline

RegisteredSep 2005

StartedAug 2004

CompletionNov 2007

Brief 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.

Trial Health

68

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

172

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Aug 2004

Typical duration for phase_2

Geographic Reach

14 countries

63 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.3 years study duration

Study Start

First participant enrolled

August 1, 2004

Completed

1.1 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed

Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

3.3 years

First QC Date

September 9, 2005

Last Update Submit

January 11, 2017

Conditions

Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

Incidence of critical, serious adverse events
Within 30 days

Secondary Outcomes (2)

Surgical drainage volume
For the duration of the trial
Amount of transfusions
For the duration of the trial

Interventions

activated recombinant human factor VIIDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Novo Nordisk A/Slead

Study Sites (63)

Novo Nordisk Investigational Site

Birmingham, Alabama, 35235, United States

Location

Novo Nordisk Investigational Site

Tucson, Arizona, 85714, United States

Location

Novo Nordisk Investigational Site

San Francisco, California, 94115, United States

Location

Novo Nordisk Investigational Site

Denver, Colorado, 80262, United States

Location

Novo Nordisk Investigational Site

Atlanta, Georgia, 30322, United States

Location

Novo Nordisk Investigational Site

Baltimore, Maryland, 21287, United States

Location

Novo Nordisk Investigational Site

Boston, Massachusetts, 02215, United States

Location

Novo Nordisk Investigational Site

Camden, New Jersey, 08103, United States

Location

Novo Nordisk Investigational Site

Syracuse, New York, 13210, United States

Location

Novo Nordisk Investigational Site

The Bronx, New York, 10461, United States

Location

Novo Nordisk Investigational Site

The Bronx, New York, 10467, United States

Location

Novo Nordisk Investigational Site

Cleveland, Ohio, 44195, United States

Location

Novo Nordisk Investigational Site

Oklahoma City, Oklahoma, 73117, United States

Location

Novo Nordisk Investigational Site

Portland, Oregon, 97207, United States

Location

Novo Nordisk Investigational Site

Danville, Pennsylvania, 17821, United States

Location

Novo Nordisk Investigational Site

Houston, Texas, 77030, United States

Location

Novo Nordisk Investigational Site

Norfolk, Virginia, 23507, United States

Location

Novo Nordisk Investigational Site

Richmond, Virginia, 23298, United States

Location

Novo Nordisk Investigational Site

Buenos Aires, C1181ACH, Argentina

Location

Novo Nordisk Investigational Site

Caba, C1093AAS, Argentina

Location

Novo Nordisk Investigational Site

Capital Federal, 1209, Argentina

Location

Novo Nordisk Investigational Site

Corrientes, 3400, Argentina

Location

Novo Nordisk Investigational Site

Rosario, 2000, Argentina

Location

Novo Nordisk Investigational Site

São Paulo, 05403-000, Brazil

Location

Novo Nordisk Investigational Site

København Ø, 2100, Denmark

Location

Novo Nordisk Investigational Site

Nantes, 44093, France

Location

Novo Nordisk Investigational Site

Vandœuvre-lès-Nancy, 54511, France

Location

Novo Nordisk Investigational Site

Aachen, 52074, Germany

Location

Novo Nordisk Investigational Site

Berlin, 10117, Germany

Location

Novo Nordisk Investigational Site

Cologne, 50924, Germany

Location

Novo Nordisk Investigational Site

Frankfurt/M., 60590, Germany

Location

Novo Nordisk Investigational Site

Krefeld, 47805, Germany

Location

Novo Nordisk Investigational Site

Leipzig, 04289, Germany

Location

Novo Nordisk Investigational Site

München, 80636, Germany

Location

Novo Nordisk Investigational Site

Ulm, 89075, Germany

Location

Novo Nordisk Investigational Site

Bangalore, 560 099, India

Location

Novo Nordisk Investigational Site

Chennai, 600 037, India

Location

Novo Nordisk Investigational Site

Chennai, 600101, India

Location

Novo Nordisk Investigational Site

New Delhi, 110025, India

Location

Novo Nordisk Investigational Site

Trivendrum, 695 011, India

Location

Novo Nordisk Investigational Site

Bologna, 40138, Italy

Location

Novo Nordisk Investigational Site

Milan, 20132, Italy

Location

Novo Nordisk Investigational Site

Roma, 00149, Italy

Location

Novo Nordisk Investigational Site

Roma, 00161, Italy

Location

Novo Nordisk Investigational Site

San Donato Milanese (MI), 20097, Italy

Location

Novo Nordisk Investigational Site

Kuala Lumpur, 50400, Malaysia

Location

Novo Nordisk Investigational Site

Singapore, 168752, Singapore

Location

Novo Nordisk Investigational Site

Johannesburg, Gauteng, 2195, South Africa

Location

Novo Nordisk Investigational Site

Durban, KwaZulu-Natal, 4001, South Africa

Location

Novo Nordisk Investigational Site

Cape Town, Western Cape, 7550, South Africa

Location

Novo Nordisk Investigational Site

Barcelona, 08035, Spain

Location

Novo Nordisk Investigational Site

Bilbao, 48013, Spain

Location

Novo Nordisk Investigational Site

Madrid, 28006, Spain

Location

Novo Nordisk Investigational Site

Madrid, 28034, Spain

Location

Novo Nordisk Investigational Site

Madrid, 28046, Spain

Location

Novo Nordisk Investigational Site

Seville, 41013, Spain

Location

Novo Nordisk Investigational Site

Lund, 221 85, Sweden

Location

Novo Nordisk Investigational Site

Cambridge, CB3 8RE, United Kingdom

Location

Novo Nordisk Investigational Site

Leicester, LE3 9QP, United Kingdom

Location

Novo Nordisk Investigational Site

London, EC1A 7BE, United Kingdom

Location

Novo Nordisk Investigational Site

London, SW3 6NP, United Kingdom

Location

Novo Nordisk Investigational Site

London, W1G 8PH, United Kingdom

Location

Novo Nordisk Investigational Site

Southampton, SO16 6YD, United Kingdom

Location

Related 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. Circulation. 2009 Jul 7;120(1):21-7. doi: 10.1161/CIRCULATIONAHA.108.834275. Epub 2009 Jun 22.
PMID: 19546387RESULT

Related Links

Clinical Trials at Novo Nordisk

Study Officials

Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

August 1, 2004

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

SG(1)IN(5)GB(6)AR(5)DE(8)DK(1)FR(2)IT(5)ZA(3)SE(1)BR(1)MY(1)ES(6)US(18)