Acquired Bleeding DisorderPhase 3CONTROLNCT00184548
Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding
A Phase 3 study testing eptacog alfa (activated) in people with Acquired Bleeding Disorder and Trauma, run by Novo Nordisk A/S at 14 sites in 14 countries.
Trial summary
This trial is conducted globally. The purpose of the trial is to evaluate that activated recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely injured trauma patients by assessing mortality and morbidity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acquired Bleeding Disorder, Trauma
- What is being tested?
- eptacog alfa (activated)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 554 participants
- Where
- 14 sitesin 14 countries
- Study dates
- Oct 2005to Sep 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trauma injury (blunt and/or penetrating) with evidence of active hemorrhage (torso and/or proximal lower extremity) refractory to blood component therapy and surgical haemostatic procedures at the time of randomisation
Who cannot join
None listed.
Trial locations and contacts
14 sites in 14 countries.
14 sites in 14 countries
United States1 site
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, 08540
About this study
Official title: A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/NiaStase®) in Severely Injured Trauma Patients With Bleeding Refractory to Standard Treatment
This trial is conducted globally. The purpose of the trial is to evaluate that activated recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely injured trauma patients by assessing mortality and morbidity.
Please note that this trial and trial F7TRAUMA-1648 (NCT00323570) have been merged.
Read the detailed description
The decision to discontinue the F7TRAUMA-1711 trial is not due to any safety concerns. The result of the pre-planned futility analysis performed in June 2008 predicted a very low likelihood of reaching a successful outcome on the primary efficacy endpoint at the end of the trial and as a consequence, the company has decided to close the trial as this juncture.
- Conditions
- Acquired Bleeding Disorder, Trauma
- Being tested
- eptacog alfa (activated), placebo
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eptacog alfa (activated)Drug
Sterile, freeze-dried powder in single-use vials to be reconstituted with sterile water for injection.
Three doses of 200, 100 and 100 mcg/kg to be administered bolus i.v. (intravenous) over approx. three hours.
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| rFVIIa, Blunt Trauma | Experimental | Not described Receives: Drug: eptacog alfa (activated) |
| Placebo, Blunt Trauma | Placebo comparator | Not described Receives: Drug: placebo |
| rVIIa, Penetrating Trauma | Experimental | Not described Receives: Drug: eptacog alfa (activated) |
| Placebo, Penetrating Trauma | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Number of participants to die from day 0 to day 30 from all causes.
Measured: from day 0 to 30
Morbidity
Morbidity reflects the number of patients who had pulmonary and/or renal dysfunction requiring ongoing medical intervention on day 30.
Measured: from day 0 to day 30
Secondary outcomes (5)
Number of Days Alive and Free of Pulmonary and/or Renal Dysfunction Requiring Medical Intervention
The number of days alive and free of pulmonary and/or renal dysfunction requiring medical intervention from day 0 to day 30.
Measured: from day 0 to day 30
Time to Death From Time of First Dose
The time of first dose refers to the time of the first dose of rFVIIa or placebo.
Measured: from day 0 to day 30
Number of Units of Transfused Red Blood Cells From Time of First Dose
The number of units of transfused red blood cells in the first 24 hours from the time of the first dose of rFVIIa or placebo.
Measured: from hour 0 to 24
Number of Patients Receiving 10 Units or More (Massive Transfusion) of Red Blood Cells From Time of Injury
The number of patients receiving 10 units or more of red blood cells in the first 24 hours from the time of injury.
Measured: from hour 0 to 24
Number of Units of All Allogeneic Transfusions From Time of First Dose
The number of units of all allogeneic transfusions in the first 24 hours from the time of the first dose of rFVIIa or placebo.
Measured: from hour 0 to 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2005
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: See termination reason in detailed description
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 554 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
- NCT00184548
- Sponsor's protocol ID
- F7TRAUMA-1711
- Other IDs
- 2005-002059-41, 2005
- Acronym
- CONTROL
- Status last verified
- Jun 2014
- First submitted
- 9 Sep 2005
- Last updated
- 25 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/NiaStase®) in Severely Injured Trauma Patients With Bleeding Refractory to Standard Treatment
- ClinicalTrials.gov ID
- NCT00184548
- Acronym / sponsor ID
- CONTROL / F7TRAUMA-1711
- Conditions
- Acquired Bleeding Disorder, Trauma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description
- Enrolment
- 554 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 26 Nov 2009
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 globally. The purpose of the trial is to evaluate that activated recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely injured trauma patients by assessing mortality and morbidity.
Please note that this trial and trial F7TRAUMA-1648 (NCT00323570) have been merged.
Detailed description
The decision to discontinue the F7TRAUMA-1711 trial is not due to any safety concerns. The result of the pre-planned futility analysis performed in June 2008 predicted a very low likelihood of reaching a successful outcome on the primary efficacy endpoint at the end of the trial and as a consequence, the company has decided to close the trial as this juncture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| rFVIIa, Blunt Trauma | Experimental | Drug: eptacog alfa (activated) |
| Placebo, Blunt Trauma | Placebo comparator | Drug: placebo |
| rVIIa, Penetrating Trauma | Experimental | Drug: eptacog alfa (activated) |
| Placebo, Penetrating Trauma | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Trauma injury (blunt and/or penetrating) with evidence of active hemorrhage (torso and/or proximal lower extremity) refractory to blood component therapy and surgical haemostatic procedures at the time of randomisation
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 |
|---|---|---|
| eptacog alfa (activated)Sterile, freeze-dried powder in single-use vials to be reconstituted with sterile water for injection. Three doses of 200, 100 and 100 mcg/kg to be administered bolus i.v. (intravenous) over approx. three hours. | Drug | rFVIIa, Blunt Trauma, rVIIa, Penetrating Trauma |
| placeboplacebo | Drug | Placebo, Blunt Trauma, Placebo, Penetrating Trauma |
Primary outcome
Mortality
Time frame: from day 0 to 30
Number of participants to die from day 0 to day 30 from all causes.
Morbidity
Time frame: from day 0 to day 30
Morbidity reflects the number of patients who had pulmonary and/or renal dysfunction requiring ongoing medical intervention on day 30.
5 secondary outcomes
Number of Days Alive and Free of Pulmonary and/or Renal Dysfunction Requiring Medical Intervention
Time frame: from day 0 to day 30
Time to Death From Time of First Dose
Time frame: from day 0 to day 30
Number of Units of Transfused Red Blood Cells From Time of First Dose
Time frame: from hour 0 to 24
Number of Patients Receiving 10 Units or More (Massive Transfusion) of Red Blood Cells From Time of Injury
Time frame: from hour 0 to 24
Number of Units of All Allogeneic Transfusions From Time of First Dose
Time frame: from hour 0 to 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
14 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing eptacog alfa (activated) in people with Acquired Bleeding Disorder and Trauma, run by Novo Nordisk A/S at 14 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 25 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Brazil, Czechia, France, Germany 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. 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?
Yes. Results are posted in the registry (first posted 26 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mortality (time frame: from day 0 to 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2014.