Congenital Bleeding DisorderPhase 1explorer™2NCT01631942
A Multi-centre, Open Labelled, Multiple Dosing Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-2021 Administered Subcutaneously to Healthy Male Subjects and Haemophilia Subjects
A Phase 1 study testing NNC172-2021 in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 6 sites in 5 countries.
Trial summary
This trial is conducted in Europe. 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 NNC 0172-2021 administered subcutaneously to healthy male subjects and subjects with haemophilia. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A, Healthy
- What is being tested?
- NNC172-2021
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 26 Jun 2012to 4 Sep 2012
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- For haemophilia subjects only: Subjects diagnosed with haemophilia A with a baseline level of Factor VIII or Factor IX below 2% without inhibitors
Who cannot join
- Known or suspected hypersensitivity to trial product(s) or related products
- Thrombocyte count below the lower limit of normal range at screening
- Any clinical signs or known history of thromboembolic events, or subject considered at high risk of thromboembolic events as judged by the investigator or subjects at increased risk of cardiovascular disease as judged by the investigator
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
France2 sites
Novo Nordisk Investigational Site
Lyon, 69003
Novo Nordisk Investigational Site
Montpellier, 34295
About this study
This trial is conducted in Europe. 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 NNC 0172-2021 administered subcutaneously to healthy male subjects and subjects with haemophilia.
Read the detailed description
The present phase 1 trial has been terminated due to the need for changes in the trial design requiring a new re-designed multiple dosing phase 1 trial. Initiation of this new trial awaits additional non-clinical data.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Healthy
- Being tested
- NNC172-2021
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC172-2021Drug
Administered as subcutaneous (s.c., under the skin) injections every other day for two weeks.
Escalation to next dose level is based on a safety evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Low dose (healthy subjects) | Experimental | Not described Receives: Drug: NNC172-2021 |
| Medium dose (subjects with haemophilia) | Experimental | Not described Receives: Drug: NNC172-2021 |
| High dose (subjects with haemophilia) | Experimental | Not described Receives: Drug: NNC172-2021 |
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 through trial day 35
Secondary outcomes (3)
Local tolerability
Measured: After the last s.c. dose administration (trial day 15)
Thrombocyte count
Measured: After the last s.c. dose administration (trial day 15)
Trough level (Ctrough)
Measured: Prior to the last s.c. dose administration (trial day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study start26 Jun 2012
- Primary completion4 Sep 2012
- Study completion4 Sep 2012
Why it stopped: See detailed description
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 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
- NCT01631942
- Sponsor's protocol ID
- NN7415-3986
- Other IDs
- 2011-005757-32, U1111-1126-0327
- Acronym
- explorer™2
- Status last verified
- May 2019
- First submitted
- 28 Jun 2012
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Waters EK, Sigh J et al.: Trombin generation is increased in plasma from healthy males who have received concizumab, an antibody against tissue factor pathway inhibitor (ExplorerTM 2); Journal of Thrombosis and Haemostasis, Abstracts 2015; 13(Suppl. S2): 1-997(AS019)
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Open Labelled, Multiple Dosing Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-2021 Administered Subcutaneously to Healthy Male Subjects and Haemophilia Subjects
- ClinicalTrials.gov ID
- NCT01631942
- Acronym / sponsor ID
- explorer™2 / NN7415-3986
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See detailed description
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2012 (actual)
- Primary completion
- 4 Sep 2012 (actual)
- Study completion
- 4 Sep 2012 (actual)
- First posted
- 29 Jun 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 investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC 0172-2021 administered subcutaneously to healthy male subjects and subjects with haemophilia.
Detailed description
The present phase 1 trial has been terminated due to the need for changes in the trial design requiring a new re-designed multiple dosing phase 1 trial. Initiation of this new trial awaits additional non-clinical data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose (healthy subjects) | Experimental | Drug: NNC172-2021 |
| Medium dose (subjects with haemophilia) | Experimental | Drug: NNC172-2021 |
| High dose (subjects with haemophilia) | Experimental | Drug: NNC172-2021 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- For haemophilia subjects only: Subjects diagnosed with haemophilia A with a baseline level of Factor VIII or Factor IX below 2% without inhibitors
Key exclusion criteria (3 listed)
- Known or suspected hypersensitivity to trial product(s) or related products
- Thrombocyte count below the lower limit of normal range at screening
- Any clinical signs or known history of thromboembolic events, or subject considered at high risk of thromboembolic events as judged by the investigator or 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 |
|---|---|---|
| NNC172-2021Administered as subcutaneous (s.c., under the skin) injections every other day for two weeks. Escalation to next dose level is based on a safety evaluation. | Drug | High dose (subjects with haemophilia), Low dose (healthy subjects), Medium dose (subjects with haemophilia) |
Primary outcome
Number of adverse events (AEs)
Time frame: From first trial drug administration through trial day 35
3 secondary outcomes
Local tolerability
Time frame: After the last s.c. dose administration (trial day 15)
Thrombocyte count
Time frame: After the last s.c. dose administration (trial day 15)
Trough level (Ctrough)
Time frame: Prior to the last s.c. dose administration (trial day 15)
Results and safety
The study was stopped early (reason given: See detailed description). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Results publicationWaters EK, Sigh J et al.: Trombin generation is increased in plasma from healthy males who have received concizumab, an antibody against tissue factor pathway inhibitor (ExplorerTM 2); Journal of Thrombosis and Haemostasis, Abstracts 2015; 13(Suppl. S2): 1-997(AS019)
- 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
6 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 NNC172-2021 in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 6 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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Austria, Germany, Spain, United Kingdom. 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 was stopped early (reason given: See detailed description). Results are not available in the source record.
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 through trial day 35). 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 NCT01631942, 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 15 May 2019.