Congenital Bleeding DisorderNCT01876745
A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan
An observational study of Congenital Bleeding Disorder and Glanzmann's Disease, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
This study is conducted in Asia. The aim of the study is to evaluate the safety and efficacy of NovoSeven® (activated recombinant factor VII, eptacog alfa (activated)) during bleeding episodes and for the prevention of bleeding during surgery/delivery in patients with Glanzmann's thrombasthenia (GT)/Glanzmann's… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Bleeding Disorder, Glanzmann's Disease
- What is being tested?
- eptacog alfa (activated)
- How many people
- 4 participants
- Where
- 1 siteJapan
- Study dates
- 7 Oct 2014to 1 Jun 2017
- 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: All patients with GT, who are enrolled in this study and to whom activated recombinant human factor VII (NovoSeven®) is administered in the study period, shall be included.
Who may be able to join
- Informed consent obtained before any study-related activities (Study related activity are any procedure related to recording of data according to the protocol).
- All-treated patients in the registration period
Who cannot join
- Known or suspected allergy to study product(s) or related products
- Septicaemia (especially, septicaemia followed severely infected patients caused by gram-negative bacteria [The risk of DIC (disseminated intravascular coagulation) caused by endotoxemia could not denied]
- Patients with a history of hypersensitivity to any of the product components
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Non-interventional, Observational Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan
This study is conducted in Asia. The aim of the study is to evaluate the safety and efficacy of NovoSeven® (activated recombinant factor VII, eptacog alfa (activated)) during bleeding episodes and for the prevention of bleeding during surgery/delivery in patients with Glanzmann's thrombasthenia (GT)/Glanzmann's disease.
- Conditions
- Congenital Bleeding Disorder, Glanzmann's Disease
- Being tested
- eptacog alfa (activated)
- Medical subject headings
- Thrombasthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eptacog alfa (activated)Drug
Also called activated recombinant factor VII, NovoSeven®
Patients will be treated according to routine clinical practice at the direction of the treating physician. Data will be collected once a year after patient is registered with baseline visit until end of the study.
| Study group | Role | What they receive |
|---|---|---|
| NovoSeven® (activated recombinant factor VII) | Not described Receives: Drug: eptacog alfa (activated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapy-related thrombosis
Measured: From onset of treatment until 6 hours after treatment onset
Secondary outcomes (2)
Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate
Measured: Within 30 days of end of treatment for bleeding episodes
Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate
Measured: Within 24 hours after surgery for surgery/delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study start7 Oct 2014
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
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
- Retrospective
- Enrolment
- 4 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
- NCT01876745
- Sponsor's protocol ID
- F7HAEM-4030
- Other IDs
- U1111-1139-9589
- Status last verified
- Jul 2017
- First submitted
- 31 May 2013
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Non-interventional, Observational Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan
- ClinicalTrials.gov ID
- NCT01876745
- Acronym / sponsor ID
- F7HAEM-4030
- Conditions
- Congenital Bleeding Disorder, Glanzmann's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2014 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 13 Jun 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 in Asia. The aim of the study is to evaluate the safety and efficacy of NovoSeven® (activated recombinant factor VII, eptacog alfa (activated)) during bleeding episodes and for the prevention of bleeding during surgery/delivery in patients with Glanzmann's thrombasthenia (GT)/Glanzmann's disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NovoSeven® (activated recombinant factor VII) | – | Drug: eptacog alfa (activated) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with GT, who are enrolled in this study and to whom activated recombinant human factor VII (NovoSeven®) is administered in the study period, shall be included.
Key inclusion criteria (2 listed)
- Informed consent obtained before any study-related activities (Study related activity are any procedure related to recording of data according to the protocol).
- All-treated patients in the registration period
Key exclusion criteria (3 listed)
- Known or suspected allergy to study product(s) or related products
- Septicaemia (especially, septicaemia followed severely infected patients caused by gram-negative bacteria [The risk of DIC (disseminated intravascular coagulation) caused by endotoxemia could not denied]
- Patients with a history of hypersensitivity to any of the product components
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)Also: activated recombinant factor VII, NovoSeven®Patients will be treated according to routine clinical practice at the direction of the treating physician. Data will be collected once a year after patient is registered with baseline visit until end of the study. | Drug | NovoSeven® (activated recombinant factor VII) |
Primary outcome
Therapy-related thrombosis
Time frame: From onset of treatment until 6 hours after treatment onset
2 secondary outcomes
Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate
Time frame: Within 30 days of end of treatment for bleeding episodes
Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate
Time frame: Within 24 hours after surgery for surgery/delivery
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 Jul 2017.
- 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?
An observational study of Congenital Bleeding Disorder and Glanzmann's Disease, run by Novo Nordisk A/S at 1 site in Japan.
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 3 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 Jul 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 Japan. 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?
Therapy-related thrombosis (time frame: From onset of treatment until 6 hours after treatment onset). 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 11 Jul 2017.