Congenital Bleeding DisorderWIRKNCT00697320
Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany
An observational study of Congenital Bleeding Disorder and Congenital FVII Deficiency, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German clinics. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Bleeding Disorder, Congenital FVII Deficiency, Glanzmann's Disease
- What is being tested?
- eptacog alfa (activated)
- Type of treatment
- Injection or infusion
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to Dec 2010
- 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: Patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven®.
Who may be able to join
- Written informed consent obtained from patient or patient's legally acceptable representative in which he agrees that the patient's pseudonymised personal data will be transferred for use in a scientific evaluation and publication
Who cannot join
- Due to the non-interventional observational character of the study, there are no exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of NovoSeven® (Activated Recombinant Human Factor VII): Non-interventional Study in Patients With Congenital Haemophilia With Inhibitors, Acquired Haemophilia, Factor FVII Deficiency, and Glanzmann's Thrombasthenia
This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German clinics. The observational study observes patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven® for treatment of a bleeding episode or for the prevention of a bleeding when undergoing surgery or an invasive procedure.
- Conditions
- Congenital Bleeding Disorder, Congenital FVII Deficiency, Glanzmann's Disease, Acquired Bleeding Disorder, Acquired Haemophilia
- 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 NovoSeven®, F7, activated recombinant human factor VII
A NON INTERVENTIONAL OBSERVATIONAL STUDY:
Doses and frequency of injections to be prescribed by the physician as a result of the normal clinical evaluation
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: eptacog alfa (activated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of acute bleeding episodes for which haemostasis (defined as stop or significant reduction of bleeding) will be achieved
Measured: within 9 hours after initiation of treatment with NovoSeven® or of invasive procedures for which haemostasis will be maintained during the time period of haemostatic coverage with NovoSeven®
Secondary outcomes (2)
Time proportion of acute bleeding treatments resulting in effective pain relief
Measured: within 9 hours after initiation of treatment with NovoSeven®
Proportion of patients experiencing one or more re-bleeds
Measured: within 24 hours after begin of an acute bleeding episode that was successfully treated with NovoSeven® (stop or significant reduction of bleeding)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2010
- Study completionDec 2010
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
- Time perspective
- Prospective
- Enrolment
- 64 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
- NCT00697320
- Sponsor's protocol ID
- F7HAEM-1921
- Acronym
- WIRK
- Status last verified
- Dec 2016
- First submitted
- 11 Jun 2008
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of NovoSeven® (Activated Recombinant Human Factor VII): Non-interventional Study in Patients With Congenital Haemophilia With Inhibitors, Acquired Haemophilia, Factor FVII Deficiency, and Glanzmann's Thrombasthenia
- ClinicalTrials.gov ID
- NCT00697320
- Acronym / sponsor ID
- WIRK / F7HAEM-1921
- Conditions
- Congenital Bleeding Disorder, Congenital FVII Deficiency, Glanzmann's Disease, Acquired Bleeding Disorder, Acquired Haemophilia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Jun 2008 (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 NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German clinics. The observational study observes patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven® for treatment of a bleeding episode or for the prevention of a bleeding when undergoing surgery or an invasive procedure.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: eptacog alfa (activated) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven®.
Key inclusion criteria (1 listed)
- Written informed consent obtained from patient or patient's legally acceptable representative in which he agrees that the patient's pseudonymised personal data will be transferred for use in a scientific evaluation and publication
Key exclusion criteria (1 listed)
- Due to the non-interventional observational character of the study, there are no exclusion criteria.
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: NovoSeven®, F7, activated recombinant human factor VIIA NON INTERVENTIONAL OBSERVATIONAL STUDY: Doses and frequency of injections to be prescribed by the physician as a result of the normal clinical evaluation | Drug | A |
Primary outcome
Proportion of acute bleeding episodes for which haemostasis (defined as stop or significant reduction of bleeding) will be achieved
Time frame: within 9 hours after initiation of treatment with NovoSeven® or of invasive procedures for which haemostasis will be maintained during the time period of haemostatic coverage with NovoSeven®
2 secondary outcomes
Time proportion of acute bleeding treatments resulting in effective pain relief
Time frame: within 9 hours after initiation of treatment with NovoSeven®
Proportion of patients experiencing one or more re-bleeds
Time frame: within 24 hours after begin of an acute bleeding episode that was successfully treated with NovoSeven® (stop or significant reduction of bleeding)
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 7 Dec 2016.
- 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 Germany.
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 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 7 Dec 2016. 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 Germany. 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?
Proportion of acute bleeding episodes for which haemostasis (defined as stop or significant reduction of bleeding) will be achieved (time frame: within 9 hours after initiation of treatment with NovoSeven® or of invasive procedures for which haemostasis will be maintained during the time period of haemostatic coverage with NovoSeven®). 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 7 Dec 2016.