Acquired Bleeding DisorderPhase 3NCT00323570
Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma
A Phase 3 study testing activated recombinant human factor VII in people with Acquired Bleeding Disorder and Trauma, run by Novo Nordisk A/S at 42 sites in United States.
Trial summary
This trial is conducted in the United States of America (USA). The purpose of this study is to evaluate the treatment of Recombinant Faction VIIa in Patients with Severe Bleeding Due to Trauma Please note that this trial and trial F7TRAUMA-1711 (NCT00184548) have been merged. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acquired Bleeding Disorder, Trauma
- What is being tested?
- activated recombinant human factor VII
- How many people
- 0 participants
- Where
- 42 sitesUnited States
- Study dates
- May 2006to Jun 2007
- 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 18 to 65 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 torso hemorrhage refectory to standard treatment
Who cannot join
None listed.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Novo Nordisk Clinical Trial Call Center
Akron, Ohio, 44304
Novo Nordisk Clinical Trial Call Center
Allentown, Pennsylvania, 18103
Novo Nordisk Clinical Trial Call Center
Baltimore, Maryland, 21201
Novo Nordisk Clinical Trial Call Center
Boston, Massachusetts, 02118
Novo Nordisk Clinical Trial Call Center
Brooklyn, New York, 11203
Novo Nordisk Clinical Trial Call Center
Camden, New Jersey, 08103
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, 60612
Novo Nordisk Clinical Trial Call Center
Cleveland, Ohio, 44109
Novo Nordisk Clinical Trial Call Center
Colorado Springs, Colorado, 80909
Novo Nordisk Clinical Trial Call Center
Columbus, Ohio, 43214
Novo Nordisk Clinical Trial Call Center
Detroit, Michigan, 48201
Novo Nordisk Clinical Trial Call Center
Fort Sam Houston, Texas, 78234-6315
Novo Nordisk Clinical Trial Call Center
Gainesville, Florida, 32610
Novo Nordisk Clinical Trial Call Center
Greenville, North Carolina, 27835-6028
Novo Nordisk Clinical Trial Call Center
Indianapolis, Indiana, 46202
Novo Nordisk Clinical Trial Call Center
Jacksonville, Florida, 32209
Novo Nordisk Clinical Trial Call Center
Lackland Air Force Base, Texas, 78236-5300
Novo Nordisk Clinical Trial Call Center
Las Vegas, Nevada, 89102
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, 90033
Novo Nordisk Clinical Trial Call Center
Louisville, Kentucky, 40202
Novo Nordisk Clinical Trial Call Center
Madison, Wisconsin, 53792
Novo Nordisk Clinical Trial Call Center
Maywood, Illinois, 60153
Novo Nordisk Clinical Trial Call Center
Memphis, Tennessee, 38163
Novo Nordisk Clinical Trial Call Center
Miami, Florida, 33136
Novo Nordisk Clinical Trial Call Center
Nashville, Tennessee, 37212
Novo Nordisk Clinical Trial Call Center
Oklahoma City, Oklahoma, 73104
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, 19102
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, 19104
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, 19140-5189
Novo Nordisk Clinical Trial Call Center
Phoenix, Arizona, 85008
Novo Nordisk Clinical Trial Call Center
Pittsburgh, Pennsylvania, 15213-2582
Novo Nordisk Clinical Trial Call Center
Portland, Maine, 04102
Novo Nordisk Clinical Trial Call Center
Portland, Oregon, 97239-3098
Novo Nordisk Clinical Trial Call Center
Providence, Rhode Island, 02903
Novo Nordisk Clinical Trial Call Center
Sacramento, California, 95817
Novo Nordisk Clinical Trial Call Center
Salt Lake City, Utah, 84143
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, 78229-3900
Novo Nordisk Clinical Trial Call Center
Springfield, Missouri, 65804
Novo Nordisk Clinical Trial Call Center
St Louis, Missouri, 63110-0250
Novo Nordisk Clinical Trial Call Center
The Bronx, New York, 10461
Novo Nordisk Clinical Trial Call Center
Washington D.C., District of Columbia, 20010-2975
Novo Nordisk Clinical Trial Call Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/ NiaStase®) in the Treatment of Refractory Bleeding in Severely Injured Trauma Patients
This trial is conducted in the United States of America (USA). The purpose of this study is to evaluate the treatment of Recombinant Faction VIIa in Patients with Severe Bleeding Due to Trauma
Please note that this trial and trial F7TRAUMA-1711 (NCT00184548) have been merged.
- Conditions
- Acquired Bleeding Disorder, Trauma
- Being tested
- activated recombinant human factor VII
- 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.
activated recombinant human factor VIIDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality and Morbidity
Measured: through day 30
Secondary outcomes (6)
All cause mortality
Hospital-free days
Number of transfusion units
Days free of renal replacement therapy
ICU-free days
Days free of ventilator support
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2006 (estimated)
- Study startMay 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bartholomew Tortella, MD, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323570
- Sponsor's protocol ID
- F7TRAUMA-1648
- Status last verified
- Mar 2012
- First submitted
- 8 May 2006
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/ NiaStase®) in the Treatment of Refractory Bleeding in Severely Injured Trauma Patients
- ClinicalTrials.gov ID
- NCT00323570
- Acronym / sponsor ID
- F7TRAUMA-1648
- Conditions
- Acquired Bleeding Disorder, Trauma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 9 May 2006 (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 the United States of America (USA). The purpose of this study is to evaluate the treatment of Recombinant Faction VIIa in Patients with Severe Bleeding Due to Trauma
Please note that this trial and trial F7TRAUMA-1711 (NCT00184548) have been merged.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 65 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 torso hemorrhage refectory to standard treatment
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
Mortality and Morbidity
Time frame: through day 30
6 secondary outcomes
All cause mortality
Hospital-free days
Number of transfusion units
Days free of renal replacement therapy
ICU-free days
Days free of ventilator support
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2012.
- 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.
Bartholomew Tortella, MD study director
Novo Nordisk A/S
42 sites 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 Trauma, run by Novo Nordisk A/S at 42 sites in United States.
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: withdrawn, as of the sponsor's last update on 27 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States. 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 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 was withdrawn before enrolling participants, so there are no results.
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 and Morbidity (time frame: through day 30). 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 27 Jun 2012.