Congenital Bleeding DisorderPhase 2NCT00108758
Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia
A Phase 2 study testing activated recombinant human factor VII in people with Congenital Bleeding Disorder and Haemophilia A With Inhibitors, run by Novo Nordisk A/S at 37 sites in 12 countries.
Trial summary
This trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA). The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B patients with inhibitors. Read more about this study
- Who is it for?
- Ages 2 years and older, men only
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- What is being tested?
- activated recombinant human factor VII
- How many people
- 23 participants
- Where
- 37 sitesin 12 countries
- Study dates
- Mar 2004to Nov 2005
- Phase
- Phase 2
- 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 2 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of congenital haemophilia A or B with inhibitors development against FVIII or FIX, respectively
Who cannot join
- Prophylactic administration of any haemostatic drug within 3 last months prior to entering the trial.
Trial locations and contacts
37 sites in 12 countries.
37 sites in 12 countries
United States13 sites
Novo Nordisk Investigational Site
Berkeley, California, 94704
Novo Nordisk Investigational Site
Boston, Massachusetts, 02115
Novo Nordisk Investigational Site
Chicago, Illinois, 60612
Novo Nordisk Investigational Site
Detroit, Michigan, 48201
Novo Nordisk Investigational Site
Houston, Texas, 77030
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46260
Novo Nordisk Investigational Site
Iowa City, Iowa, 52242
Novo Nordisk Investigational Site
Los Angeles, California, 90027
Novo Nordisk Investigational Site
New Hyde Park, New York, 11042
Novo Nordisk Investigational Site
New Orleans, Louisiana, 70112-2699
Novo Nordisk Investigational Site
Newark, New Jersey, 07112
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19104
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19134-1095
Brazil5 sites
Novo Nordisk Investigational Site
Belo Horizonte, 10130-110
Novo Nordisk Investigational Site
Campinas, São Paulo, 13081970
Novo Nordisk Investigational Site
Recife, 52011-000
Novo Nordisk Investigational Site
Ribeirão Preto, 14051-140
Novo Nordisk Investigational Site
Rio de Janeiro, Rio de Janeiro, 20211-030
Poland4 sites
Novo Nordisk Investigational Site
Gdansk, 80-952
Novo Nordisk Investigational Site
Lublin, 20-954
Novo Nordisk Investigational Site
Warsaw, 00-576
Novo Nordisk Investigational Site
Warsaw, 00-791
France3 sites
Novo Nordisk Investigational Site
Le Kremlin-Bicêtre, 94270
Novo Nordisk Investigational Site
Lille, 59037
Novo Nordisk Investigational Site
Paris, 75015
Spain3 sites
Novo Nordisk Investigational Site
Madrid, 28046
Novo Nordisk Investigational Site
Santander, 39008
Novo Nordisk Investigational Site
Seville, 41013
Romania2 sites
Novo Nordisk Investigational Site
Bucharest, 022328
Novo Nordisk Investigational Site
Timișoara, Timiș County, 300011
Turkey (Türkiye)2 sites
Novo Nordisk Investigational Site
Bornova-IZMIR, 35100
Novo Nordisk Investigational Site
Capa-ISTANBUL, 35100
Argentina1 site
Novo Nordisk Investigational Site
Ciudad Autónoma de Bs. As., C1425ASU
South Africa1 site
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 2193
About this study
Official title: Exploratory, Multi-centre, Randomised, Double-blind, Uncontrolled Trial Evaluating the Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Secondary Bleeding Prophylaxis in Congenital Haemophilia A or B Patients With Inhibitors
This trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA).
The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B patients with inhibitors.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of bleeds
Measured: During 3 months treatment period as compared to 3 months observation period
Secondary outcomes (1)
Efficacy variables
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2005 (estimated)
- Study startMar 2004
- Primary completionNov 2005
- Study completionNov 2005
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 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
- NCT00108758
- Sponsor's protocol ID
- F7HAEM-1505
- Status last verified
- Jan 2017
- First submitted
- 18 Apr 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Konkle BA, Ebbesen LS, Erhardtsen E, Bianco RP, Lissitchkov T, Rusen L, Serban MA. Randomized, prospective clinical trial of recombinant factor VIIa for secondary prophylaxis in hemophilia patients with inhibitors. J Thromb Haemost. 2007 Sep;5(9):1904-13. doi: 10.1111/j.1538-7836.2007.02663.x.
PubMed 17723130
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory, Multi-centre, Randomised, Double-blind, Uncontrolled Trial Evaluating the Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Secondary Bleeding Prophylaxis in Congenital Haemophilia A or B Patients With Inhibitors
- ClinicalTrials.gov ID
- NCT00108758
- Acronym / sponsor ID
- F7HAEM-1505
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 19 Apr 2005 (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 trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA).
The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B patients with inhibitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 2 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of congenital haemophilia A or B with inhibitors development against FVIII or FIX, respectively
Key exclusion criteria (1 listed)
- Prophylactic administration of any haemostatic drug within 3 last months prior to entering the trial.
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 VII | Drug | – |
Primary outcome
Reduction of bleeds
Time frame: During 3 months treatment period as compared to 3 months observation period
1 secondary outcome
Efficacy variables
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 12 Jan 2017.
- Results publication: PubMed 17723130Konkle BA, Ebbesen LS, Erhardtsen E, Bianco RP, Lissitchkov T, Rusen L, Serban MA. Randomized, prospective clinical trial of recombinant factor VIIa for secondary prophylaxis in hemophilia patients with inhibitors. J Thromb Haemost. 2007 Sep;5(9):1904-13. doi: 10.1111/j.1538-7836.2007.02663.x.
- 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
37 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing activated recombinant human factor VII in people with Congenital Bleeding Disorder and Haemophilia A With Inhibitors, run by Novo Nordisk A/S at 37 sites in 12 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 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 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Brazil, Poland, France, Spain and 7 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction of bleeds (time frame: During 3 months treatment period as compared to 3 months observation period). 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 NCT00108758, 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 12 Jan 2017.