Congenital Bleeding Disordermentor™6NCT01862367
Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study
An observational study of Congenital Bleeding Disorder and Congenital FXIII Deficiency, run by Novo Nordisk A/S at 17 sites in 6 countries.
Trial summary
This study is conducted globally. The aim of this observational study is to investigate the incidence of specific adverse drug reactions associated with the use of recombinant factor XIII (NovoThirteen®) in patients with congenital FXIII A-subunit deficiency (congenital FXIII deficiency), comprising FXIII antibodies… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Bleeding Disorder, Congenital FXIII Deficiency
- What is being tested?
- catridecacog
- How many people
- 30 participants
- Where
- 17 sitesin 6 countries
- Study dates
- 17 May 2013to 26 Jun 2019
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This observational study will enroll patients with congenital FXIII A-subunit deficiency for whom the decision to treat with rFXIII has been made and who are willing to provide informed consent (or patient's legally acceptable representative (LAR) consent, if applicable).
Who may be able to join
- Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)
- Able and willing to provide signed informed consent (or patient's legally acceptable representative (LAR) consent, if applicable), as required by local ethics committee, governmental or regulatory authorities
- Congenital FXIII A-subunit deficiency
- Actual or planned exposure to rFXIII
Who cannot join
None listed.
Trial locations and contacts
17 sites in 6 countries.
17 sites in 6 countries
United States7 sites
Novo Nordisk Investigational Site
Atlanta, Georgia, 30322
Novo Nordisk Investigational Site
Cleveland, Ohio, 44106
Novo Nordisk Investigational Site
Columbus, Ohio, 43205
Novo Nordisk Investigational Site
Detroit, Michigan, 48201
Novo Nordisk Investigational Site
Minneapolis, Minnesota, 55404
Novo Nordisk Investigational Site
Orange, California, 92868
Novo Nordisk Investigational Site
Tampa, Florida, 33607
Spain4 sites
Novo Nordisk Investigational Site
Barcelona, 08035
Novo Nordisk Investigational Site
Madrid, 28046
Novo Nordisk Investigational Site
Málaga, 29011
Novo Nordisk Investigational Site
Tortosa, 43500
Canada2 sites
Novo Nordisk Investigational Site
St. John's, Newfoundland and Labrador, A1B 3V6
Novo Nordisk Investigational Site
Toronto, Ontario, M5G 1X8
Italy2 sites
Novo Nordisk Investigational Site
Chieti, 66100
Novo Nordisk Investigational Site
Genova, 16147
United Kingdom1 site
Novo Nordisk Investigational Site
Aberdeen, AB25 2ZN
About this study
This study is conducted globally. The aim of this observational study is to investigate the incidence of specific adverse drug reactions associated with the use of recombinant factor XIII (NovoThirteen®) in patients with congenital FXIII A-subunit deficiency (congenital FXIII deficiency), comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect.
The study will aim at observing all patients exposed to NovoThirteen® in the EU, and additional patients from selected non-EU countries. Recombinant FXIII (rFXIII) is registered in EU and Switzerland as NovoThirteen® and in Canada as Tretten®.
- Being tested
- catridecacog
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catridecacogDrug
Also called recombinant factor XIII
No treatment given. All patients enrolled in this observational study will receive their medication through usual commercial channels.
| Study group | Role | What they receive |
|---|---|---|
| rFXIII | Not described Receives: Drug: catridecacog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse drug reactions in patients with congenital FXIII A-subunit deficiency treated with rFXIII,comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of effect collected
Measured: During study period up to 6 years
Secondary outcomes (5)
All serious adverse events collected
Measured: During study period up to 6 years
All medical events of special interest collected
Measured: During study period up to 6 years
All medication errors and near medication errors collected
Measured: During study period up to 6 years
Use of rFXIII in patients with congenital FXIII A-subunit deficiency also for other uses than for prophylactic treatment collected
Measured: During study period up to 6 years
Frequency of bleeding episodes collected
Measured: During study period up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study start17 May 2013
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 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
- NCT01862367
- Sponsor's protocol ID
- NN1841-3868
- Other IDs
- U1111-1131-1558, ENCEPP/SDPP/3687
- Acronym
- mentor™6
- Status last verified
- Jul 2019
- First submitted
- 21 May 2013
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study
- ClinicalTrials.gov ID
- NCT01862367
- Acronym / sponsor ID
- mentor™6 / NN1841-3868
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 17 May 2013 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 24 May 2013 (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 study is conducted globally. The aim of this observational study is to investigate the incidence of specific adverse drug reactions associated with the use of recombinant factor XIII (NovoThirteen®) in patients with congenital FXIII A-subunit deficiency (congenital FXIII deficiency), comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect.
The study will aim at observing all patients exposed to NovoThirteen® in the EU, and additional patients from selected non-EU countries. Recombinant FXIII (rFXIII) is registered in EU and Switzerland as NovoThirteen® and in Canada as Tretten®.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rFXIII | – | Drug: catridecacog |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This observational study will enroll patients with congenital FXIII A-subunit deficiency for whom the decision to treat with rFXIII has been made and who are willing to provide informed consent (or patient's legally acceptable representative (LAR) consent, if applicable).
Key inclusion criteria (4 listed)
- Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)
- Able and willing to provide signed informed consent (or patient's legally acceptable representative (LAR) consent, if applicable), as required by local ethics committee, governmental or regulatory authorities
- Congenital FXIII A-subunit deficiency
- Actual or planned exposure to rFXIII
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 |
|---|---|---|
| catridecacogAlso: recombinant factor XIIINo treatment given. All patients enrolled in this observational study will receive their medication through usual commercial channels. | Drug | rFXIII |
Primary outcome
Adverse drug reactions in patients with congenital FXIII A-subunit deficiency treated with rFXIII,comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of effect collected
Time frame: During study period up to 6 years
5 secondary outcomes
All serious adverse events collected
Time frame: During study period up to 6 years
All medical events of special interest collected
Time frame: During study period up to 6 years
All medication errors and near medication errors collected
Time frame: During study period up to 6 years
Use of rFXIII in patients with congenital FXIII A-subunit deficiency also for other uses than for prophylactic treatment collected
Time frame: During study period up to 6 years
Frequency of bleeding episodes collected
Time frame: During study period up to 6 years
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 9 Jul 2019.
- 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
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Bleeding Disorder and Congenital FXIII Deficiency, run by Novo Nordisk A/S at 17 sites in 6 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 4 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: finished, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Spain, Canada, Italy, Hungary and 1 more country. 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.
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?
Adverse drug reactions in patients with congenital FXIII A-subunit deficiency treated with rFXIII,comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of effect collected (time frame: During study period up to 6 years). 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 9 Jul 2019.