Congenital Bleeding DisorderPhase 1NCT02084810
Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male Subjects
A Phase 1 study testing activated recombinant human factor VII and eptacog alfa (activated) in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S.
Trial summary
This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence of eptacog alfa A 6 mg and NovoSeven® in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors
- What is being tested?
- activated recombinant human factor VII and eptacog alfa (activated)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Jul 2014
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, age 18-55 years, both inclusive, at the time of signing informed consent
- Body Mass Index (BMI) 18.5-30 kg/m^2, both inclusive
- Good general health based on assessment of medical history, vital signs, physical examination, ECG (electrocardiogram), and laboratory data at screening, as judged by the investigator
Who cannot join
- Known history of thromboembolic event(s) or potential thromboembolic risk as judged by the investigator
About this study
Official title: A Single Centre, Randomised, Double-blind, Two-way Crossover Trial in Healthy Male Subjects Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven®
This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence of eptacog alfa A 6 mg and NovoSeven® in healthy male subjects.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B, Haemophilia B With Inhibitors, Healthy
- Being tested
- activated recombinant human factor VII, eptacog alfa (activated)
- 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
All subjects will receive one i.v. (intravenous, into the vein) injection of 90μg/kg.
Each subject will be allocated to two treatment periods separated by a wash-out period of a week.
eptacog alfa (activated)Drug
All subjects will receive one i.v. injection of 90μg/kg. Each subject will be allocated to two treatment periods separated by a wash-out period of a week.
| Study group | Role | What they receive |
|---|---|---|
| NovoSeven® | Active comparator | Not described Receives: Drug: activated recombinant human factor VII |
| Eptacog alfa A 6 mg | Experimental | Not described Receives: Drug: eptacog alfa (activated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve
Measured: After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose
Maximum concentration
Measured: After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose
Secondary outcomes (2)
Frequency of adverse events (including serious adverse events)
Measured: Assessed up to 7 weeks following first trial product administration
Incidence of antibodies
Measured: Assessed up to 7 weeks following first trial product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 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
- NCT02084810
- Sponsor's protocol ID
- NN7777-4087
- Other IDs
- 2013-003163-63, U1111-1145-6620
- Status last verified
- Mar 2014
- First submitted
- 28 Jan 2014
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Randomised, Double-blind, Two-way Crossover Trial in Healthy Male Subjects Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven®
- ClinicalTrials.gov ID
- NCT02084810
- Acronym / sponsor ID
- NN7777-4087
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B, Haemophilia B With Inhibitors, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 12 Mar 2014 (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 the trial is to investigate the bioequivalence of eptacog alfa A 6 mg and NovoSeven® in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NovoSeven® | Active comparator | Drug: activated recombinant human factor VII |
| Eptacog alfa A 6 mg | Experimental | Drug: eptacog alfa (activated) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male, age 18-55 years, both inclusive, at the time of signing informed consent
- Body Mass Index (BMI) 18.5-30 kg/m^2, both inclusive
- Good general health based on assessment of medical history, vital signs, physical examination, ECG (electrocardiogram), and laboratory data at screening, as judged by the investigator
Key exclusion criteria (1 listed)
- Known history of thromboembolic event(s) or potential thromboembolic risk as judged by the investigator
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 VIIAll subjects will receive one i.v. (intravenous, into the vein) injection of 90μg/kg. Each subject will be allocated to two treatment periods separated by a wash-out period of a week. | Drug | NovoSeven® |
| eptacog alfa (activated)All subjects will receive one i.v. injection of 90μg/kg. Each subject will be allocated to two treatment periods separated by a wash-out period of a week. | Drug | Eptacog alfa A 6 mg |
Primary outcome
Area under the curve
Time frame: After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose
Maximum concentration
Time frame: After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose
2 secondary outcomes
Frequency of adverse events (including serious adverse events)
Time frame: Assessed up to 7 weeks following first trial product administration
Incidence of antibodies
Time frame: Assessed up to 7 weeks following first trial product administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing activated recombinant human factor VII and eptacog alfa (activated) in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S.
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 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: withdrawn, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 curve (time frame: After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose). The study lists 2 primary outcomes in all. 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 26 Mar 2014.