Acquired Bleeding DisorderPhase 1NCT01561417
Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects
A Phase 1 study testing activated recombinant human factor VII in people with Acquired Bleeding Disorder and Acquired Haemophilia, run by Novo Nordisk A/S at 1 site in France.
Trial summary
This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Acquired Bleeding Disorder, Acquired Haemophilia, Congenital Bleeding Disorder
- What is being tested?
- activated recombinant human factor VII
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2006to Sep 2006
- 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 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Caucasian
- Body Mass Index (BMI) between 18 and 27 kg/m^2, both inclusive
- Good health as indicated by medical history, physical examination including vital signs and ECG, and clinical laboratory test results
- Smoke less than 10 cigarettes (or equivalent) per day
- Capable of giving written Informed Consent (IC)
Who cannot join
- Evidence of clinically relevant pathology or potential thromboembolic risk based on medical and/or family history as judged by the Investigator
- Known history of atherosclerosis, arteriosclerosis, thromboembolic events or known high levels of Troponin I
- Known or suspected allergy to activated recombinant human factor VII or related products or any of the components of the formulation
- Overt bleeding, including from gastrointestinal tract
- Hepatitis (B or C) infection
- HIV (human immunodeficiency virus) infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Randomised, Double-blind, Two-way Cross-over Trial Investigating the Bio-equivalence in Healthy Male Subjects of NovoSeven (CP-rFVIIa) and a Formulation of NovoSeven Stable at 25°C (VII25)
This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25).
- Conditions
- Acquired Bleeding Disorder, Acquired Haemophilia, Congenital Bleeding Disorder, Congenital FVII Deficiency, Glanzmann's Disease, Haemophilia A With Inhibitors
- Being tested
- activated recombinant human factor VII
- Medical subject headings
- Thrombasthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activated recombinant human factor VIIDrug
One single dose administration, injected i.v. (into the vein)
activated recombinant human factor VIIDrug
One single dose administration, injected i.v. (into the vein)
| Study group | Role | What they receive |
|---|---|---|
| CP-rFVIIa | Active comparator | Not described Receives: Drug: activated recombinant human factor VII |
| VII25 | Experimental | 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.
Area under the plasma concentration versus time curve for FVIIa clot activity
Secondary outcomes (2)
The maximum plasma concentration (Cmax)
Terminal half-life (t½)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startApr 2006
- Primary completionSep 2006
- Study completionSep 2006
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 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 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
- NCT01561417
- Sponsor's protocol ID
- NN1007-1744
- Other IDs
- 2005-005379-14, 2005
- Status last verified
- Jan 2017
- First submitted
- 21 Mar 2012
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bysted BV, Scharling B, Moller T, Hansen BL. A randomized, double-blind trial demonstrating bioequivalence of the current recombinant activated factor VII formulation and a new robust 25 degrees C stable formulation. Haemophilia. 2007 Sep;13(5):527-32. doi: 10.1111/j.1365-2516.2007.01516.x.
PubMed 17880439
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Randomised, Double-blind, Two-way Cross-over Trial Investigating the Bio-equivalence in Healthy Male Subjects of NovoSeven (CP-rFVIIa) and a Formulation of NovoSeven Stable at 25°C (VII25)
- ClinicalTrials.gov ID
- NCT01561417
- Acronym / sponsor ID
- NN1007-1744
- Conditions
- Acquired Bleeding Disorder, Acquired Haemophilia, Congenital Bleeding Disorder, Congenital FVII Deficiency, Glanzmann's Disease, Haemophilia A With Inhibitors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 23 Mar 2012 (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. The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CP-rFVIIa | Active comparator | Drug: activated recombinant human factor VII |
| VII25 | Experimental | Drug: activated recombinant human factor VII |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Caucasian
- Body Mass Index (BMI) between 18 and 27 kg/m^2, both inclusive
- Good health as indicated by medical history, physical examination including vital signs and ECG, and clinical laboratory test results
- Smoke less than 10 cigarettes (or equivalent) per day
- Capable of giving written Informed Consent (IC)
Key exclusion criteria (6 listed)
- Evidence of clinically relevant pathology or potential thromboembolic risk based on medical and/or family history as judged by the Investigator
- Known history of atherosclerosis, arteriosclerosis, thromboembolic events or known high levels of Troponin I
- Known or suspected allergy to activated recombinant human factor VII or related products or any of the components of the formulation
- Overt bleeding, including from gastrointestinal tract
- Hepatitis (B or C) infection
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 VIIOne single dose administration, injected i.v. (into the vein) | Drug | CP-rFVIIa |
| activated recombinant human factor VIIOne single dose administration, injected i.v. (into the vein) | Drug | VII25 |
Primary outcome
Area under the plasma concentration versus time curve for FVIIa clot activity
2 secondary outcomes
The maximum plasma concentration (Cmax)
Terminal half-life (t½)
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 19 Jan 2017.
- Results publication: PubMed 17880439Bysted BV, Scharling B, Moller T, Hansen BL. A randomized, double-blind trial demonstrating bioequivalence of the current recombinant activated factor VII formulation and a new robust 25 degrees C stable formulation. Haemophilia. 2007 Sep;13(5):527-32. doi: 10.1111/j.1365-2516.2007.01516.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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing activated recombinant human factor VII in people with 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 5 inclusion and 6 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 19 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 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.
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?
Area under the plasma concentration versus time curve for FVIIa clot activity. 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 NCT01561417, 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 19 Jan 2017.