Acquired Bleeding DisorderACQUI-7NCT01285089
Observational Study on the Use of NovoSeven® for Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia
An observational study of Acquired Bleeding Disorder and Acquired Haemophilia, run by Novo Nordisk A/S at 1 site in France.
Trial summary
This study is conducted in Europe. The aim of this prospective, observational study are to describe the different clinical practice and detailed haemostatic management of activated recombinant human factor VII (NovoSeven®) in patients with acquired haemophilia in France. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acquired Bleeding Disorder, Acquired Haemophilia
- What is being tested?
- activated recombinant human factor VII
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2010to Oct 2013
- 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: Any patient diagnosed with acquired haemophilia and treated with at least one injection of activated recombinant human factor VII can be included in the study. The treatment will be performed according the local practice.
Who may be able to join
- Diagnosed with acquired haemophilia
- Treated with activated recombinant human factor VII as first line treatment
- Treated with activated recombinant human factor VII after January 2011
Who cannot join
- Patients with first diagnosis before january 2010 and having a relapse after january 2011
- Known hypersensitivity to NovoSeven®, or to mouse, hamster or bovine protein
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective French Study on ACQUIred Haemophilia Treatment With Recombinant Factor VIIa (NovoSeven®) A Prospective Observational Study on the Use of NovoSeven® (Activated Recombinant Human Factor VIIa) for the Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia
This study is conducted in Europe. The aim of this prospective, observational study are to describe the different clinical practice and detailed haemostatic management of activated recombinant human factor VII (NovoSeven®) in patients with acquired haemophilia in France. The secondary aim is to assess the primary haemostasis disorder associated with the coagulation disorders, if available.
- Conditions
- Acquired Bleeding Disorder, Acquired Haemophilia
- 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 collection of the use of activated recombinant human factor VII observed through real-world treatment practices
| 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.
Identification of decision criteria to treat patient with activated recombinant human factor VII
Measured: Year 3
Secondary outcomes (1)
Number of patients with a control of bleeding
Measured: Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionOct 2013
- Study completionOct 2013
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 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
- NCT01285089
- Sponsor's protocol ID
- F7HAEM-3856
- Other IDs
- U1111-1114-8926
- Acronym
- ACQUI-7
- Status last verified
- Jan 2014
- First submitted
- 26 Jan 2011
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective French Study on ACQUIred Haemophilia Treatment With Recombinant Factor VIIa (NovoSeven®) A Prospective Observational Study on the Use of NovoSeven® (Activated Recombinant Human Factor VIIa) for the Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia
- ClinicalTrials.gov ID
- NCT01285089
- Acronym / sponsor ID
- ACQUI-7 / F7HAEM-3856
- Conditions
- Acquired Bleeding Disorder, Acquired Haemophilia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 27 Jan 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 Europe. The aim of this prospective, observational study are to describe the different clinical practice and detailed haemostatic management of activated recombinant human factor VII (NovoSeven®) in patients with acquired haemophilia in France. The secondary aim is to assess the primary haemostasis disorder associated with the coagulation disorders, if available.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- 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
- Any patient diagnosed with acquired haemophilia and treated with at least one injection of activated recombinant human factor VII can be included in the study. The treatment will be performed according the local practice.
Key inclusion criteria (3 listed)
- Diagnosed with acquired haemophilia
- Treated with activated recombinant human factor VII as first line treatment
- Treated with activated recombinant human factor VII after January 2011
Key exclusion criteria (2 listed)
- Patients with first diagnosis before january 2010 and having a relapse after january 2011
- Known hypersensitivity to NovoSeven®, or to mouse, hamster or bovine protein
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 collection of the use of activated recombinant human factor VII observed through real-world treatment practices | Drug | A |
Primary outcome
Identification of decision criteria to treat patient with activated recombinant human factor VII
Time frame: Year 3
1 secondary outcome
Number of patients with a control of bleeding
Time frame: Year 3
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 30 Jan 2014.
- 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 Acquired Bleeding Disorder and Acquired Haemophilia, run by Novo Nordisk A/S at 1 site in France.
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 2 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 30 Jan 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 France. 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?
Identification of decision criteria to treat patient with activated recombinant human factor VII (time frame: Year 3). 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 30 Jan 2014.