Acquired Bleeding DisorderPhase 2NCT00154427
Use of Activated Recombinant Human Factor VII in Cardiac Surgery
A Phase 2 study testing activated recombinant human factor VII in people with Acquired Bleeding Disorder and Cardiac Surgery Requiring Cardiopulmonary Bypass, run by Novo Nordisk A/S at 63 sites in 14 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
- What is being tested?
- activated recombinant human factor VII
- How many people
- 172 participants
- Where
- 63 sitesin 14 countries
- Study dates
- Aug 2004to Nov 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-operative bleeding according to pre-defined criteria for critical bleeding
Who cannot join
None listed.
Trial locations and contacts
63 sites in 14 countries.
63 sites in 14 countries
United States18 sites
Novo Nordisk Investigational Site
Atlanta, Georgia, 30322
Novo Nordisk Investigational Site
Baltimore, Maryland, 21287
Novo Nordisk Investigational Site
Birmingham, Alabama, 35235
Novo Nordisk Investigational Site
Boston, Massachusetts, 02215
Novo Nordisk Investigational Site
Camden, New Jersey, 08103
Novo Nordisk Investigational Site
Cleveland, Ohio, 44195
Novo Nordisk Investigational Site
Danville, Pennsylvania, 17821
Novo Nordisk Investigational Site
Denver, Colorado, 80262
Novo Nordisk Investigational Site
Houston, Texas, 77030
Novo Nordisk Investigational Site
Norfolk, Virginia, 23507
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, 73117
Novo Nordisk Investigational Site
Portland, Oregon, 97207
Novo Nordisk Investigational Site
Richmond, Virginia, 23298
Novo Nordisk Investigational Site
San Francisco, California, 94115
Novo Nordisk Investigational Site
Syracuse, New York, 13210
Novo Nordisk Investigational Site
The Bronx, New York, 10461
Novo Nordisk Investigational Site
The Bronx, New York, 10467
Novo Nordisk Investigational Site
Tucson, Arizona, 85714
Germany8 sites
Novo Nordisk Investigational Site
Aachen, 52074
Novo Nordisk Investigational Site
Berlin, 10117
Novo Nordisk Investigational Site
Cologne, 50924
Novo Nordisk Investigational Site
Frankfurt/M., 60590
Novo Nordisk Investigational Site
Krefeld, 47805
Novo Nordisk Investigational Site
Leipzig, 04289
Novo Nordisk Investigational Site
München, 80636
Novo Nordisk Investigational Site
Ulm, 89075
Spain6 sites
Novo Nordisk Investigational Site
Barcelona, 08035
Novo Nordisk Investigational Site
Bilbao, 48013
Novo Nordisk Investigational Site
Madrid, 28006
Novo Nordisk Investigational Site
Madrid, 28034
Novo Nordisk Investigational Site
Madrid, 28046
Novo Nordisk Investigational Site
Seville, 41013
United Kingdom6 sites
Novo Nordisk Investigational Site
Cambridge, CB3 8RE
Novo Nordisk Investigational Site
Leicester, LE3 9QP
Novo Nordisk Investigational Site
London, EC1A 7BE
Novo Nordisk Investigational Site
London, SW3 6NP
Novo Nordisk Investigational Site
London, W1G 8PH
Novo Nordisk Investigational Site
Southampton, SO16 6YD
Argentina5 sites
Novo Nordisk Investigational Site
Buenos Aires, C1181ACH
Novo Nordisk Investigational Site
Caba, C1093AAS
Novo Nordisk Investigational Site
Capital Federal, 1209
Novo Nordisk Investigational Site
Corrientes, 3400
Novo Nordisk Investigational Site
Rosario, 2000
India5 sites
Novo Nordisk Investigational Site
Bangalore, 560 099
Novo Nordisk Investigational Site
Chennai, 600 037
Novo Nordisk Investigational Site
Chennai, 600101
Novo Nordisk Investigational Site
New Delhi, 110025
Novo Nordisk Investigational Site
Trivendrum, 695 011
Italy5 sites
Novo Nordisk Investigational Site
Bologna, 40138
Novo Nordisk Investigational Site
Milan, 20132
Novo Nordisk Investigational Site
Roma, 00149
Novo Nordisk Investigational Site
Roma, 00161
Novo Nordisk Investigational Site
San Donato Milanese (MI), 20097
South Africa3 sites
Novo Nordisk Investigational Site
Cape Town, Western Cape, 7550
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4001
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 2195
France2 sites
Novo Nordisk Investigational Site
Nantes, 44093
Novo Nordisk Investigational Site
Vandœuvre-lès-Nancy, 54511
About this study
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
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.
- Being tested
- activated recombinant human factor VII
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activated recombinant human factor VIIDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of critical, serious adverse events
Measured: Within 30 days
Secondary outcomes (2)
Surgical drainage volume
Measured: For the duration of the trial
Amount of transfusions
Measured: For the duration of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionNov 2007
- Study completionNov 2007
Why it stopped: Trial terminated after recruiting 172 patients but without proceeding to the highest dosing cohort as this no longer reflects common clinical practice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired Bleeding DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154427
- Sponsor's protocol ID
- F7CARD-1610
- Other IDs
- 2004-000100-40, 2004
- Status last verified
- Jan 2017
- First submitted
- 9 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19546387
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00154427
- Acronym / sponsor ID
- F7CARD-1610
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial terminated after recruiting 172 patients but without proceeding to the highest dosing cohort as this no longer reflects common clinical practice
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Post-operative bleeding according to pre-defined criteria for critical bleeding
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| activated recombinant human factor VII | Drug | – |
Primary outcome
Incidence of critical, serious adverse events
Time frame: Within 30 days
2 secondary outcomes
Surgical drainage volume
Time frame: For the duration of the trial
Amount of transfusions
Time frame: For the duration of the trial
Results and safety
The study was stopped early (reason given: Trial terminated after recruiting 172 patients but without proceeding to the highest dosing cohort as this no longer reflects common clinical practice). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Results publication: PubMed 19546387Gill 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.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Acquired Bleeding Disorder
RecruitingPhase 3
A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
Haemophilia A
RecruitingPhase 3
Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
Acquired Fibrinogen Deficiency
RecruitingObservational study
Point of Care Fibrinogen Measurement in Trauma Patients in the Emergency Department
Trauma Induced Coagulopathy, Trauma Coagulopathy
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 3
Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
Acquired Antithrombin Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
63 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing activated recombinant human factor VII in people with Acquired Bleeding Disorder and Cardiac Surgery Requiring Cardiopulmonary Bypass, run by Novo Nordisk A/S at 63 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Germany, Spain, United Kingdom, Argentina and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Trial terminated after recruiting 172 patients but without proceeding to the highest dosing cohort as this no longer reflects common clinical practice). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of critical, serious adverse events (time frame: Within 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00154427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.