Congenital Bleeding DisorderNCT01312636
Observational Study on Safety and Efficacy of NovoSeven® in Subjects With Congenital FVII Deficiency
An observational study of Congenital Bleeding Disorder and Congenital FVII Deficiency, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
This study is conducted in Japan. The aim of this observational study is to evaluate the long-term safety and efficacy of activated recombinant human factor VII (NovoSeven®) in subjects with congenital FVII deficiency. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Bleeding Disorder, Congenital FVII Deficiency
- What is being tested?
- activated recombinant human factor VII
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2011to Sep 2014
- 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 subjects with a FVII deficiency to whom activated recombinant human factor VII (NovoSeven®) is administered
Who may be able to join
- Congenital FVII deficiency
- Never been treated with NovoSeven® before
- Patients already in treatment with NovoSeven®
Who cannot join
- History of hypersensitivity to any of the components in NovoSeven®
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Congenital FVII Deficiency - Registry for All Treated Patients
This study is conducted in Japan. The aim of this observational study is to evaluate the long-term safety and efficacy of activated recombinant human factor VII (NovoSeven®) in subjects with congenital FVII deficiency.
- Being tested
- activated recombinant human factor VII
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activated recombinant human factor VIIDrug
Data will be collected at the baseline visit and approximately once a year until end of study.
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: activated recombinant human factor VII |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence and/or the appearance of inhibiting antibodies to factor VII and/or therapy-related thrombosis on using NovoSeven® under normal clinical practice conditions
Measured: once a year in years 1-4
Secondary outcomes (2)
To assess the treatment evaluation for bleeding episodes
Measured: year 1, year 4
To assess the course and outcome of pregnancy in women treated with novoseven
Measured: until 1 month after giving birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2014
- Study completionSep 2014
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 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
- Enrolment
- 36 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
- NCT01312636
- Sponsor's protocol ID
- F7HAEM-3862
- Other IDs
- U1111-1116-1529
- Status last verified
- Oct 2014
- First submitted
- 2 Mar 2011
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Seita I, Kinai E. A multicenter, observational study to evaluate hemostasis following recombinant activated FVII treatment in patients in Japan with congenital factor VII deficiency. Blood Coagul Fibrinolysis. 2023 Jul 1;34(5):295-304. doi: 10.1097/MBC.0000000000001225. Epub 2023 Jun 23.
PubMed 37395185
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Congenital FVII Deficiency - Registry for All Treated Patients
- ClinicalTrials.gov ID
- NCT01312636
- Acronym / sponsor ID
- F7HAEM-3862
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 Mar 2011 (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 Japan. The aim of this observational study is to evaluate the long-term safety and efficacy of activated recombinant human factor VII (NovoSeven®) in subjects with congenital FVII deficiency.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: activated recombinant human factor VII |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All subjects with a FVII deficiency to whom activated recombinant human factor VII (NovoSeven®) is administered
Key inclusion criteria (3 listed)
- Congenital FVII deficiency
- Never been treated with NovoSeven® before
- Patients already in treatment with NovoSeven®
Key exclusion criteria (1 listed)
- History of hypersensitivity to any of the components in NovoSeven®
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 VIIData will be collected at the baseline visit and approximately once a year until end of study. | Drug | A |
Primary outcome
Presence and/or the appearance of inhibiting antibodies to factor VII and/or therapy-related thrombosis on using NovoSeven® under normal clinical practice conditions
Time frame: once a year in years 1-4
2 secondary outcomes
To assess the treatment evaluation for bleeding episodes
Time frame: year 1, year 4
To assess the course and outcome of pregnancy in women treated with novoseven
Time frame: until 1 month after giving birth
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 20 Oct 2014.
- Derived from this study: PubMed 37395185Seita I, Kinai E. A multicenter, observational study to evaluate hemostasis following recombinant activated FVII treatment in patients in Japan with congenital factor VII deficiency. Blood Coagul Fibrinolysis. 2023 Jul 1;34(5):295-304. doi: 10.1097/MBC.0000000000001225. Epub 2023 Jun 23.
- 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 Congenital FVII Deficiency, 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 3 inclusion and 1 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 20 Oct 2014. 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?
Presence and/or the appearance of inhibiting antibodies to factor VII and/or therapy-related thrombosis on using NovoSeven® under normal clinical practice conditions (time frame: once a year in years 1-4). 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 NCT01312636, 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 20 Oct 2014.