Acquired Bleeding DisorderPhase 3NCT01562574
Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
A Phase 3 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 1 site in Australia.
Trial summary
This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of activated recombinant human factor VII and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary bypass (CPB) surgery for paediatric congenital heart disease. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
- What is being tested?
- activated recombinant human factor VII
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2002to Aug 2004
- Phase
- Phase 3
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed informed consent obtained from parent or legal guardian before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject
- Children with complex congenital heart disease requiring corrective surgery with cardiopulmonary bypass (CPB)
Who cannot join
- Congenital heart disease that does not require CPB surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Parallel Group, Placebo-controlled Comparison of Recombi-nant Factor VIIa (rFVIIa/ NovoSeven®) With Standard Haemostatic Replacement Therapy, and Standard Haemostatic Replacement Ther-apy Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of activated recombinant human factor VII and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary bypass (CPB) surgery for paediatric congenital heart disease.
- Being tested
- activated recombinant human factor VII, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activated recombinant human factor VIIDrug
Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered
placeboDrug
Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered
| Study group | Role | What they receive |
|---|---|---|
| Activated recombinant human factor VII | Experimental | Not described Receives: Drug: activated recombinant human factor VII |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from reversal of heparin with protamine sulphate to chest closure
Secondary outcomes (3)
Number of units/volume of fresh frozen plasma (FFP) and/or platelets and/or red-cell concentrates transfused during surgery and in the post-surgery period
Blood loss
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startJan 2002
- Primary completionAug 2004
- Study completionAug 2004
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 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
- NCT01562574
- Sponsor's protocol ID
- F7CPB-3343
- Status last verified
- Jan 2017
- First submitted
- 22 Mar 2012
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ekert H, Brizard C, Eyers R, Cochrane A, Henning R. Elective administration in infants of low-dose recombinant activated factor VII (rFVIIa) in cardiopulmonary bypass surgery for congenital heart disease does not shorten time to chest closure or reduce blood loss and need for transfusions: a randomized, double-blind, parallel group, placebo-controlled study of rFVIIa and standard haemostatic replacement therapy versus standard haemostatic replacement therapy. Blood Coagul Fibrinolysis. 2006 Jul;17(5):389-95. doi: 10.1097/01.mbc.0000233369.03358.c1.
PubMed 16788315
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 Randomised, Double-blind, Parallel Group, Placebo-controlled Comparison of Recombi-nant Factor VIIa (rFVIIa/ NovoSeven®) With Standard Haemostatic Replacement Therapy, and Standard Haemostatic Replacement Ther-apy Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT01562574
- Acronym / sponsor ID
- F7CPB-3343
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 26 Mar 2012 (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 Oceania. The aim of this trial is to investigate the efficacy of activated recombinant human factor VII and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary bypass (CPB) surgery for paediatric congenital heart disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activated recombinant human factor VII | Experimental | Drug: activated recombinant human factor VII |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Signed informed consent obtained from parent or legal guardian before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject
- Children with complex congenital heart disease requiring corrective surgery with cardiopulmonary bypass (CPB)
Key exclusion criteria (1 listed)
- Congenital heart disease that does not require CPB surgery
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 VIIUp to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered | Drug | Activated recombinant human factor VII |
| placeboUp to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered | Drug | Placebo |
Primary outcome
Time from reversal of heparin with protamine sulphate to chest closure
3 secondary outcomes
Number of units/volume of fresh frozen plasma (FFP) and/or platelets and/or red-cell concentrates transfused during surgery and in the post-surgery period
Blood loss
Adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Results publication: PubMed 16788315Ekert H, Brizard C, Eyers R, Cochrane A, Henning R. Elective administration in infants of low-dose recombinant activated factor VII (rFVIIa) in cardiopulmonary bypass surgery for congenital heart disease does not shorten time to chest closure or reduce blood loss and need for transfusions: a randomized, double-blind, parallel group, placebo-controlled study of rFVIIa and standard haemostatic replacement therapy versus standard haemostatic replacement therapy. Blood Coagul Fibrinolysis. 2006 Jul;17(5):389-95. doi: 10.1097/01.mbc.0000233369.03358.c1.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 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 1 site in Australia.
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 2 inclusion and 1 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: finished, 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 1 site in Australia. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time from reversal of heparin with protamine sulphate to chest closure. 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 NCT01562574, 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.