Congenital Bleeding DisorderNCT01220141
Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B
An observational study of Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 14 sites in 14 countries.
Trial summary
This study is conducted in Europe and Asia. The aim of this observational study is to monitor antibody formation towards the room temperature stable formulation of NovoSeven® (activated recombinant human factor VII). Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- What is being tested?
- activated recombinant human factor VII
- How many people
- 51 participants
- Where
- 14 sitesin 14 countries
- Study dates
- Nov 2010to Mar 2015
- 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
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male patients with haemophilia A or B with inhibitors treated with room temperature stable NovoSeven® (activated recombinant human factor VII).
Who may be able to join
- Diagnosed with congenital haemophilia A or B with inhibitors to factor VIII or factor IX
- Treated with room temperature stable NovoSeven®
Who cannot join
None listed.
Trial locations and contacts
14 sites in 14 countries.
14 sites in 14 countries
About this study
Official title: Prospective Observational Study on NovoSeven® Room Temperature Stable (VII25) in Patients With Haemophilia A or B
This study is conducted in Europe and Asia. The aim of this observational study is to monitor antibody formation towards the room temperature stable formulation of NovoSeven® (activated recombinant human factor VII).
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Being tested
- activated recombinant human factor VII
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activated recombinant human factor VIIDrug
Administration of room temperature stable NovoSeven® (activated recombinant human factor VII) in dosages prescribed by the treating physician according to the product labelling text approved in his country.
| 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.
Reduced therapeutic response and neutralising antibodies to activated recombinant human factor VII as confirmed by central laboratory
Measured: after 25 exposure days
Secondary outcomes (1)
Adverse events reported as potentially related to activated recombinant human factor VII
Measured: after 25 exposure days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2015
- Study completionMar 2015
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
- 51 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
- NCT01220141
- Sponsor's protocol ID
- NN7025-3601
- Other IDs
- U1111-1116-2012
- Status last verified
- Apr 2015
- First submitted
- 12 Oct 2010
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on NovoSeven® Room Temperature Stable (VII25) in Patients With Haemophilia A or B
- ClinicalTrials.gov ID
- NCT01220141
- Acronym / sponsor ID
- NN7025-3601
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Oct 2010 (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 and Asia. The aim of this observational study is to monitor antibody formation towards the room temperature stable formulation of NovoSeven® (activated recombinant human factor VII).
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
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male patients with haemophilia A or B with inhibitors treated with room temperature stable NovoSeven® (activated recombinant human factor VII).
Key inclusion criteria (2 listed)
- Diagnosed with congenital haemophilia A or B with inhibitors to factor VIII or factor IX
- Treated with room temperature stable NovoSeven®
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 |
|---|---|---|
| activated recombinant human factor VIIAdministration of room temperature stable NovoSeven® (activated recombinant human factor VII) in dosages prescribed by the treating physician according to the product labelling text approved in his country. | Drug | A |
Primary outcome
Reduced therapeutic response and neutralising antibodies to activated recombinant human factor VII as confirmed by central laboratory
Time frame: after 25 exposure days
1 secondary outcome
Adverse events reported as potentially related to activated recombinant human factor VII
Time frame: after 25 exposure days
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 16 Apr 2015.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Congenital Bleeding Disorder
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 1
Topical TOR-582 Treatment of Epistaxis in HHT
Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis
RecruitingPhase 1/2
Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia (HHT), Osler Weber Rendu Disease
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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
14 sites in 14 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 Haemophilia A, run by Novo Nordisk A/S at 14 sites in 14 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 2 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 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Argentina, Austria, Belgium, France, Germany and 9 more countries. 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?
Reduced therapeutic response and neutralising antibodies to activated recombinant human factor VII as confirmed by central laboratory (time frame: after 25 exposure days). 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 16 Apr 2015.