Congenital Bleeding DisorderPhase 1NCT02490787
Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects
A Phase 1 study testing Concizumab in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 34 sites in 15 countries.
Trial summary
This trial is conducted globally. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of concizumab administered subcutaneously to haemophilia A subjects. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men only
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A
- What is being tested?
- Concizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 34 sitesin 15 countries
- Study dates
- 10 Sep 2015to 14 Oct 2016
- 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 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male subjects diagnosed with haemophilia A without inhibitors present at screening and currently treated on-demand
- Subjects with a baseline level of factor VIII below or equal to 2 % based on medical records
- Age between 18 and 64 years both inclusive, at the time of signing informed consent
- Body weight between 50 and 100 kg, both inclusive
Who cannot join
- Known or suspected hypersensitivity to trial product or related products
- Platelet count below 50x10^9/L at screening
- Any clinical signs or known history of thromboembolic events, or subjects considered at high risk of thromboembolic events as judged by the investigator
- Subjects at increased risk of cardiovascular disease as judged by the investigator
Trial locations and contacts
34 sites in 15 countries.
34 sites in 15 countries
United States8 sites
Novo Nordisk Investigational Site
Baltimore, Maryland, 21287
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
Milwaukee, Wisconsin, 53226
Novo Nordisk Investigational Site
New York, New York, 10065
Novo Nordisk Investigational Site
Portland, Oregon, 97239
Novo Nordisk Investigational Site
Torrance, California, 90502-2004
United Kingdom4 sites
Novo Nordisk Investigational Site
London, NW3 2QG
Novo Nordisk Investigational Site
London, SW17 0QT
Novo Nordisk Investigational Site
Sheffield, S10 2JF
Novo Nordisk Investigational Site
Southampton, SO16 6YD
France3 sites
Novo Nordisk Investigational Site
Bron, 69677
Novo Nordisk Investigational Site
Nantes, 44093
Novo Nordisk Investigational Site
Rennes, 35033
Germany3 sites
Novo Nordisk Investigational Site
Berlin, 10249
Novo Nordisk Investigational Site
Duisburg, 47051
Novo Nordisk Investigational Site
Homburg, 66421
Netherlands3 sites
Novo Nordisk Investigational Site
Amsterdam, 1105 AZ
Novo Nordisk Investigational Site
Nijmegen, 6525 GA
Novo Nordisk Investigational Site
Utrecht, 3584 CX
Australia2 sites
Novo Nordisk Investigational Site
Camperdown, New South Wales, 2050
Novo Nordisk Investigational Site
Melbourne, Victoria, 3004
Malaysia2 sites
Novo Nordisk Investigational Site
Kuala Lumpur, 50400
Novo Nordisk Investigational Site
Kuching, 93586
Ukraine2 sites
Novo Nordisk Investigational Site
Dnipropetrovsk, 49102
Novo Nordisk Investigational Site
Lviv, 79044
Turkey (Türkiye)1 site
Novo Nordisk Investigational Site
Bornova-IZMIR, 35100
About this study
Official title: A Multi-centre, Randomised, Placebo Controlled, Double Blinded, Multiple Dose Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects (Explorer™3)
This trial is conducted globally. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of concizumab administered subcutaneously to haemophilia A subjects.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A
- Being tested
- Concizumab, placebo
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConcizumabDrug
Administered subcutaneously (s.c., under the skin) at five different dose levels (ranging from 0.25 to 1.5 mg/kg)
placeboDrug
Administered subcutaneously (s.c., under the skin)
| Study group | Role | What they receive |
|---|---|---|
| Concizumab | Experimental | Not described Receives: Drug: Concizumab; Drug: placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events (AEs)
Measured: From first trial drug administration (day 1) to 11 weeks after the first trial product administration
Secondary outcomes (2)
Trough level of concizumab
Measured: Prior to the last s.c. dose administration (day 42)
Frequency of binding non-neutralizing anti-concizumab antibodies
Measured: From first trial drug administration (day 1) to 11 weeks after the 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 posted7 Jul 2015 (estimated)
- Study start10 Sep 2015
- Primary completion14 Oct 2016
- Study completion14 Oct 2016
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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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
- NCT02490787
- Sponsor's protocol ID
- NN7415-4159
- Other IDs
- 2014-003793-16, U1111-1161-1501, NL53826.018.15, 2014
- Status last verified
- Jul 2017
- First submitted
- 2 Jul 2015
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised, Placebo Controlled, Double Blinded, Multiple Dose Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects (Explorer™3)
- ClinicalTrials.gov ID
- NCT02490787
- Acronym / sponsor ID
- NN7415-4159
- Conditions
- Congenital Bleeding Disorder, Haemophilia A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2015 (actual)
- Primary completion
- 14 Oct 2016 (actual)
- Study completion
- 14 Oct 2016 (actual)
- First posted
- 7 Jul 2015 (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 globally. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of concizumab administered subcutaneously to haemophilia A subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concizumab | Experimental | Drug: Concizumab, Drug: placebo |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male subjects diagnosed with haemophilia A without inhibitors present at screening and currently treated on-demand
- Subjects with a baseline level of factor VIII below or equal to 2 % based on medical records
- Age between 18 and 64 years both inclusive, at the time of signing informed consent
- Body weight between 50 and 100 kg, both inclusive
Key exclusion criteria (4 listed)
- Known or suspected hypersensitivity to trial product or related products
- Platelet count below 50x10^9/L at screening
- Any clinical signs or known history of thromboembolic events, or subjects considered at high risk of thromboembolic events as judged by the investigator
- Subjects at increased risk of cardiovascular disease 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 |
|---|---|---|
| ConcizumabAdministered subcutaneously (s.c., under the skin) at five different dose levels (ranging from 0.25 to 1.5 mg/kg) | Drug | Concizumab |
| placeboAdministered subcutaneously (s.c., under the skin) | Drug | Concizumab, Placebo |
Primary outcome
Number of adverse events (AEs)
Time frame: From first trial drug administration (day 1) to 11 weeks after the first trial product administration
2 secondary outcomes
Trough level of concizumab
Time frame: Prior to the last s.c. dose administration (day 42)
Frequency of binding non-neutralizing anti-concizumab antibodies
Time frame: From first trial drug administration (day 1) to 11 weeks after the first trial product administration
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 21 Jul 2017.
- 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
34 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Concizumab in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 34 sites in 15 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 4 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 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, United Kingdom, France, Germany, Netherlands and 10 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. Some participants in this study may receive a placebo. 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?
Number of adverse events (AEs) (time frame: From first trial drug administration (day 1) to 11 weeks after the first trial product administration). 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 21 Jul 2017.