Congenital Bleeding DisorderPhase 1NCT00837356
Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects
A Phase 1 study testing Advate® and turoctocog alfa in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 7 sites in 5 countries.
Trial summary
This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia A subjects, investigating the action and safety of the drugs. Read more about this study
- Who is it for?
- Ages 12 to 55 years, men only
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A
- What is being tested?
- Advate® and turoctocog alfa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 7 sitesin 5 countries
- Study dates
- Mar 2009to Oct 2009
- Phase
- Phase 1
- 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 12 to 55 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Severe haemophilia A (FVIII level less than or equal to 1%)
- Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products
- HIV or HCV negative, or if positive the patient is on a stable antiviral regimen at the time of the enrolment in the trial
Who cannot join
- Presence of any bleeding disorder in addition to haemophilia A
- Inhibitor titre greater than or equal to 0.6 Bethesda Units (BU) at screening and past history of inhibitor
- Abnormal renal function tests
- Known hypersensitivity to Advate®
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Germany2 sites
Novo Nordisk Investigational Site
Berlin, 10249
Novo Nordisk Investigational Site
Hanover, 30625
Italy2 sites
Novo Nordisk Investigational Site
Florence, 50134
Novo Nordisk Investigational Site
Milan, 20124
About this study
Official title: A Multi-centre, Multi-national Open-label Sequential Trial Comparing Pharmacokinetics and Safety of N8 and Advate® in Subjects With Haemophilia A
This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia A subjects, investigating the action and safety of the drugs.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A
- Being tested
- Advate®, turoctocog alfa
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advate®Drug
Subjects will receive Advate® at a dose of 50 IU/kg body weight in the first session
turoctocog alfaDrug
Also called recombinant FVIII, N8
After a washout period of 4 days, subjects will subsequently receive turoctocog alfa (recombinant factor VIII (N8)) at a dose of 50 IU/kg body weight in the second session
| Study group | Role | What they receive |
|---|---|---|
| Advate®/turoctocog alfa | Experimental | Not described Receives: Drug: Advate®; Drug: turoctocog alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of FVIII 30 min after administration, half-life, AUC, and clearance
Measured: at 30 days
Secondary outcomes (1)
Inhibitor development
Measured: at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2009
- Study completionOct 2009
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- NCT00837356
- Sponsor's protocol ID
- NN7008-3522
- Other IDs
- 2008-002157-21, 2008
- Status last verified
- Feb 2017
- First submitted
- 4 Feb 2009
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Martinowitz U, Bjerre J, Brand B, Klamroth R, Misgav M, Morfini M, Santagostino E, Tiede A, Viuff D. Bioequivalence between two serum-free recombinant factor VIII preparations (N8 and ADVATE(R))--an open-label, sequential dosing pharmacokinetic study in patients with severe haemophilia A. Haemophilia. 2011 Nov;17(6):854-9. doi: 10.1111/j.1365-2516.2011.02495.x. Epub 2011 Mar 28.
PubMed 21443634
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Multi-national Open-label Sequential Trial Comparing Pharmacokinetics and Safety of N8 and Advate® in Subjects With Haemophilia A
- ClinicalTrials.gov ID
- NCT00837356
- Acronym / sponsor ID
- NN7008-3522
- Conditions
- Congenital Bleeding Disorder, Haemophilia A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 5 Feb 2009 (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 Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia A subjects, investigating the action and safety of the drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advate®/turoctocog alfa | Experimental | Drug: Advate®, Drug: turoctocog alfa |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Severe haemophilia A (FVIII level less than or equal to 1%)
- Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products
- HIV or HCV negative, or if positive the patient is on a stable antiviral regimen at the time of the enrolment in the trial
Key exclusion criteria (4 listed)
- Presence of any bleeding disorder in addition to haemophilia A
- Inhibitor titre greater than or equal to 0.6 Bethesda Units (BU) at screening and past history of inhibitor
- Abnormal renal function tests
- Known hypersensitivity to Advate®
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 |
|---|---|---|
| Advate®Subjects will receive Advate® at a dose of 50 IU/kg body weight in the first session | Drug | Advate®/turoctocog alfa |
| turoctocog alfaAlso: recombinant FVIII, N8After a washout period of 4 days, subjects will subsequently receive turoctocog alfa (recombinant factor VIII (N8)) at a dose of 50 IU/kg body weight in the second session | Drug | Advate®/turoctocog alfa |
Primary outcome
Recovery of FVIII 30 min after administration, half-life, AUC, and clearance
Time frame: at 30 days
1 secondary outcome
Inhibitor development
Time frame: at 30 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 10 Feb 2017.
- Results publication: PubMed 21443634Martinowitz U, Bjerre J, Brand B, Klamroth R, Misgav M, Morfini M, Santagostino E, Tiede A, Viuff D. Bioequivalence between two serum-free recombinant factor VIII preparations (N8 and ADVATE(R))--an open-label, sequential dosing pharmacokinetic study in patients with severe haemophilia A. Haemophilia. 2011 Nov;17(6):854-9. doi: 10.1111/j.1365-2516.2011.02495.x. Epub 2011 Mar 28.
- 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
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Advate® and turoctocog alfa in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 7 sites in 5 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 3 inclusion and 4 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 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Italy, Israel, Spain, Switzerland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Recovery of FVIII 30 min after administration, half-life, AUC, and clearance (time frame: at 30 days). 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 NCT00837356, 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 10 Feb 2017.