Acquired Bleeding DisorderPhase 1NCT02239146
Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass
A Phase 1 study testing catridecacog in people with Acquired Bleeding Disorder and Cardiac Surgery Requiring Cardiopulmonary Bypass, run by Novo Nordisk A/S at 24 sites in 5 countries.
Trial summary
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first time myocardial revascularization requiring cardiopulmonary bypass (CPB). Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
- What is being tested?
- catridecacog
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 24 sitesin 5 countries
- Study dates
- Oct 2005to Jan 2008
- Phase
- Phase 1
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is undergoing his/her first myocardial revascularization
Who cannot join
- Previous participation (randomisation and dosing) in this trial
- Subject has a history of cerebrovascular event (including thrombotic or haemorrhagic stroke or transient ischaemic attack (TIA)) and/or extra-myocardial thromboembolic events, e.g., deep vein thrombosis (DVT) or pulmonary embolus (PE)
- Subject required a pre-operative (within 30 days) transfusion of any blood and/or blood product
- Subject has a current atrial fibrillation or history of atrial fibrillation
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
United States15 sites
Novo Nordisk Investigational Site
Allentown, Pennsylvania, 18103
Novo Nordisk Investigational Site
Camden, New Jersey, 08103
Novo Nordisk Investigational Site
Cleveland, Ohio, 44195
Novo Nordisk Investigational Site
Denver, Colorado, 80262
Novo Nordisk Investigational Site
Houston, Texas, 77030
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46290
Novo Nordisk Investigational Site
New York, New York, 10032
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107-5092
Novo Nordisk Investigational Site
Portland, Oregon, 97207
Novo Nordisk Investigational Site
Portland, Oregon, 97239-3098
Novo Nordisk Investigational Site
Richmond, Virginia, 23298
Novo Nordisk Investigational Site
San Francisco, California, 94143
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
United Kingdom4 sites
Novo Nordisk Investigational Site
Cambridge, CB3 8RE
Novo Nordisk Investigational Site
London, W1G 8PH
Novo Nordisk Investigational Site
Middlesbrough, TS4 3BW
Novo Nordisk Investigational Site
Southampton, SO16 6YD
Germany3 sites
Novo Nordisk Investigational Site
Hamburg, 20246
Novo Nordisk Investigational Site
Lahr, 77933
Novo Nordisk Investigational Site
Mainz, 55131
About this study
Official title: A Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Escalation Trial on Safety and Pharmacokinetics of Recombinant Factor XIII (rFXIII) in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first time myocardial revascularization requiring cardiopulmonary bypass (CPB).
- Being tested
- catridecacog, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catridecacogDrug
Single doses of rFXIII administered intravenously (i.v.) to eight subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg).
placeboDrug
Single doses of placebo administered intravenously (i.v.) to two subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg).
| Study group | Role | What they receive |
|---|---|---|
| rFXIII | Experimental | Not described Receives: Drug: catridecacog |
| 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.
Incidence and severity of adverse events
Measured: From dosing up to 5-7 weeks ± 3 days after trial product administration
Secondary outcomes (3)
Incidence and magnitude of laboratory abnormalities following administration of rFXIII
Measured: From dosing up to 5-7 weeks ± 3 days after trial product administration
Incidence of antibodies to FXIII-A subunit
Measured: From dosing up to 5-7 weeks ± 3 days after trial product administration
Incidence of anti-yeast antibodies
Measured: From dosing up to 5-7 weeks ± 3 days after trial product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startOct 2005
- Primary completionJan 2008
- Study completionJan 2008
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 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
- NCT02239146
- Sponsor's protocol ID
- F13CARD-1660
- Other IDs
- 2005-000729-40, 2005
- Status last verified
- Jan 2017
- First submitted
- 10 Sep 2014
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Levy JH, Gill R, Nussmeier NA, Olsen PS, Andersen HF, Booth FV, Jespersen CM. Repletion of factor XIII following cardiopulmonary bypass using a recombinant A-subunit homodimer. A preliminary report. Thromb Haemost. 2009 Oct;102(4):765-71. doi: 10.1160/TH08-12-0826.
PubMed 19806264
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Escalation Trial on Safety and Pharmacokinetics of Recombinant Factor XIII (rFXIII) in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT02239146
- Acronym / sponsor ID
- F13CARD-1660
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 12 Sep 2014 (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 Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first time myocardial revascularization requiring cardiopulmonary bypass (CPB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rFXIII | Experimental | Drug: catridecacog |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject is undergoing his/her first myocardial revascularization
Key exclusion criteria (4 listed)
- Previous participation (randomisation and dosing) in this trial
- Subject has a history of cerebrovascular event (including thrombotic or haemorrhagic stroke or transient ischaemic attack (TIA)) and/or extra-myocardial thromboembolic events, e.g., deep vein thrombosis (DVT) or pulmonary embolus (PE)
- Subject required a pre-operative (within 30 days) transfusion of any blood and/or blood product
- Subject has a current atrial fibrillation or history of atrial fibrillation
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 |
|---|---|---|
| catridecacogSingle doses of rFXIII administered intravenously (i.v.) to eight subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg). | Drug | rFXIII |
| placeboSingle doses of placebo administered intravenously (i.v.) to two subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg). | Drug | Placebo |
Primary outcome
Incidence and severity of adverse events
Time frame: From dosing up to 5-7 weeks ± 3 days after trial product administration
3 secondary outcomes
Incidence and magnitude of laboratory abnormalities following administration of rFXIII
Time frame: From dosing up to 5-7 weeks ± 3 days after trial product administration
Incidence of antibodies to FXIII-A subunit
Time frame: From dosing up to 5-7 weeks ± 3 days after trial product administration
Incidence of anti-yeast antibodies
Time frame: From dosing up to 5-7 weeks ± 3 days after trial product administration
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 11 Jan 2017.
- Results publication: PubMed 19806264Levy JH, Gill R, Nussmeier NA, Olsen PS, Andersen HF, Booth FV, Jespersen CM. Repletion of factor XIII following cardiopulmonary bypass using a recombinant A-subunit homodimer. A preliminary report. Thromb Haemost. 2009 Oct;102(4):765-71. doi: 10.1160/TH08-12-0826.
- 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
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing catridecacog in people with Acquired Bleeding Disorder and Cardiac Surgery Requiring Cardiopulmonary Bypass, run by Novo Nordisk A/S at 24 sites in 5 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 4 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 11 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 24 sites in United States, United Kingdom, Germany, Canada, Denmark. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence and severity of adverse events (time frame: From dosing up to 5-7 weeks ± 3 days after trial product administration). 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 NCT02239146, 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 11 Jan 2017.