Congenital Bleeding DisorderPhase 2explorer™4NCT03196284
A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors
A Phase 2 study testing Concizumab and Eptacog alfa in people with Congenital Bleeding Disorder and Haemophilia A With Inhibitors, run by Novo Nordisk A/S at 22 sites in 14 countries.
Trial summary
This trial is conducted in Africa, Asia, Europe and North America. The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- What is being tested?
- Concizumab and Eptacog alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 22 sitesin 14 countries
- Study dates
- 10 Aug 2017to 31 Jan 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: - Informed consent obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine the suitability for the trial - Male haemophilia A or B patients with inhibitors aged 18 years or older at the time of signing informed consent - Patients currently in need of treatment with bypassing agents Exclusion Criteria: - Known or suspected hypersensitivity to trial product(s) or related products - Known inherited or acquired bleeding disorder other than haemophilia - Ongoing or planned immune tolerance induction therapy or prophylaxis with FVIII or FIX
Trial locations and contacts
22 sites in 14 countries.
22 sites in 14 countries
United States3 sites
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46260
Novo Nordisk Investigational Site
Iowa City, Iowa, 52242
Novo Nordisk Investigational Site
Los Angeles, California, 90027
Japan3 sites
Novo Nordisk Investigational Site
Aichi, 466-8560
Novo Nordisk Investigational Site
Nara, 634-8522
Novo Nordisk Investigational Site
Tokyo, 167-0035
Italy2 sites
Novo Nordisk Investigational Site
Florence, 50134
Novo Nordisk Investigational Site
Milan, 20124
Malaysia2 sites
Novo Nordisk Investigational Site
Georgetown, Penang, 10450
Novo Nordisk Investigational Site
Kota Kinabalu, 88586
Spain2 sites
Novo Nordisk Investigational Site
Madrid, 28046
Novo Nordisk Investigational Site
Seville, 41013
United Kingdom2 sites
Novo Nordisk Investigational Site
London, SE1 7EH
Novo Nordisk Investigational Site
Sheffield, S10 2JF
About this study
Official title: A Multi-Centre, Randomised, Open-Label, Controlled Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors
This trial is conducted in Africa, Asia, Europe and North America. The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Being tested
- Concizumab, Eptacog alfa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConcizumabDrug
A loading dose of 0.5 mg/kg will be given as the first dose, followed by 0.15 mg/kg (with potential stepwise dose escalation to 0.25 mg/kg) administered daily s.c. (subcutaneously, under the skin). Treatment duration is 24 weeks in the main trial, and up to 52 weeks in the extension phase
Eptacog alfaDrug
A single dose of 90 μg/kg eptacog alfa one week after dosing with concizumab. On-demand treatment during bleeding episodes in both treatment arms
| Study group | Role | What they receive |
|---|---|---|
| Concizumab | Experimental | Concizumab administered in both the main phase and extension phase, with eptacog alfa administered on-demand during bleeding episodes Receives: Drug: Concizumab; Drug: Eptacog alfa |
| Eptacog alfa and concizumab | Active comparator | Eptacog alfa administered on-demand during bleeding episodes as the only intervention during the main phase. Concizumab given in the extension phase Receives: Drug: Concizumab; Drug: Eptacog alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Bleeding Episodes
The number of bleeding episodes that were treated during at least 24 weeks from treatment onset (week 0) are presented.
Measured: During at least 24 weeks from treatment onset (week 0)
Secondary outcomes (30)
The Number of Bleeding Episodes
The number of bleeding episodes that were treated during at least 76 weeks from treatment onset (week 0) are presented. This outcome measure is applicable for only 'Concizumab' treatment arm.
Measured: During at least 76 weeks from treatment onset (week 0)
The Number of Spontaneous Bleeding Episodes
Bleeds that were not linked to a specific, known action or event are called spontaneous bleeding episodes. The number of spontaneous bleeding episodes that were treated during at least 24 weeks from treatment onset (week 0) are presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: During at least 24 weeks from treatment onset (week 0)
The Number of Spontaneous Bleeding Episodes
Bleeds that were not linked to a specific, known action or event are called spontaneous bleeding episodes. The number of spontaneous bleeding episodes that were treated during at least 76 weeks from treatment onset (week 0) are presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: During at least 76 weeks from treatment onset (week 0)
Number of Treatment-emergent Adverse Events (TEAEs) During at Least 24 Weeks From Treatment Onset
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily had a causal relationship with this treatment. A TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. Number of TEAEs that occurred during at least 24 weeks from treatment onset (week 0) are presented. The data is presented per the dose level which the participants have reached at the time of event.
Measured: During at least 24 weeks from treatment onset (week 0)
Number of Treatment-emergent Adverse Events (TEAEs) During at Least 76 Weeks From Treatment Onset
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily had a causal relationship with this treatment. A TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. Number of TEAEs that occurred during at least 76 weeks from treatment onset (week 0) are presented. The data is presented per the dose level which the participants have reached at the time of event.
Measured: During at least 76 weeks from treatment onset (week 0)
Number of Treatment-emergent Adverse Events (TEAEs) Within 24 Hours After Eptacog Alfa Administration
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily had a causal relationship with this treatment. A TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. Number of TEAEs that occurred within 24 hours after eptacog alfa administration are presented. This outcome measure is applicable only for 'Eptacog alfa' treatment arm.
Measured: Within 24 hours after eptacog alfa administration
Occurrence of Anti-concizumab Antibodies During at Least 24 Weeks From Treatment Onset
Occurrence of anti-concizumab antibodies during at least 24 weeks from treatment onset (week 0) is presented. This outcome measure is applicable for only 'Concizumab' treatment arm.
Measured: During at least 24 weeks from treatment onset (week 0)
Occurrence of Anti-concizumab Antibodies During at Least 76 Weeks From Treatment Onset
Occurrence of anti-concizumab antibodies during at least 76 weeks from treatment onset (week 0) is presented. This outcome measure is applicable for only 'Concizumab' treatment arm.
Measured: During at least 76 weeks from treatment onset (week 0)
Change in Fibrinogen
Change in fibrinogen during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: During at least 24 weeks from treatment onset (week 0)
Change in Fibrinogen
Change in fibrinogen during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: During at least 76 weeks from treatment onset (week 0)
Change in D-dimer
Change in D-dimer during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: During at least 24 weeks from treatment onset (week 0)
Change in D-dimer
Change in D-dimer during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: During at least 76 weeks from treatment onset (week 0)
Change in Prothrombin Fragment 1 + 2 (F1 + 2)
Change in F1 + 2 during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: During at least 24 weeks from treatment onset (week 0)
Change in Prothrombin Fragment 1 + 2 (F1 + 2)
Change in F1 + 2 during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: During at least 76 weeks from treatment onset (week 0)
Change in Prothrombin Time (PT)
Change in PT during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: During at least 24 weeks from treatment onset (week 0)
Change in Prothrombin Time (PT)
Change in PT during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: During at least 76 weeks from treatment onset (week 0)
Change in Activated Partial Thromboplastin Time (APTT)
Change in APTT during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: During at least 24 weeks from treatment onset (week 0)
Change in Activated Partial Thromboplastin Time (APTT)
Change in APTT during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: During at least 76 weeks from treatment onset (week 0)
Change in Anti-thrombin (AT)
Change in AT during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: During at least 24 weeks from treatment onset (week 0)
Change in Anti-thrombin (AT)
Change in AT after at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: After at least 76 weeks from treatment onset (week 0)
Concentration of Concizumab
Concentration of concizumab prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: Prior to the last dose administration at 24 weeks
Concentration of Concizumab
Concentration of concizumab prior to the last dose administration after atleast 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: Prior to the last dose administration after atleast 76 weeks
Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value
Free TFPI (TFPI not bound to concizumab) concentration value prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: Prior to the last dose administration at 24 weeks
Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value
Free TFPI concentration value prior to the last dose administration after atleast 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: Prior to the last dose administration after atleast 76 weeks
Peak Thrombin Generation
Peak thrombin generation is the maximal concentration of thrombin formed at a given point in time. Peak thrombin generation prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: Prior to the last dose administration at 24 weeks
Peak Thrombin Generation
Peak thrombin generation is the maximal concentration of thrombin formed at a given point in time. Peak thrombin generation prior to the last dose administration after atleast 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: Prior to the last dose administration after atleast 76 weeks
Endogenous Thrombin Potential
Endogenous thrombin potential prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: Prior to the last dose administration at 24 weeks
Endogenous Thrombin Potential
Endogenous thrombin potential prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: Prior to the last dose administration after atleast 76 weeks
Thrombin Generation Velocity Index
Thrombin generation velocity index prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: Prior to the last dose administration at 24 weeks
Thrombin Generation Velocity Index
Thrombin generation velocity index prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Measured: Prior to the last dose administration after atleast 76 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start10 Aug 2017
- Primary completion19 Sep 2018
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196284
- Sponsor's protocol ID
- NN7415-4310
- Other IDs
- U1111-1179-2925, 2016-000510-30, JapicCTI-173681, 2016
- Acronym
- explorer™4
- Status last verified
- Sep 2021
- First submitted
- 20 Jun 2017
- Last updated
- 22 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to disclosure commitment on novonordisk-trials.com
Publications
Shapiro AD, Angchaisuksiri P, Astermark J, Benson G, Castaman G, Eichler H, Jimenez-Yuste V, Kavakli K, Matsushita T, Poulsen LH, Wheeler AP, Young G, Zupancic-Salek S, Oldenburg J, Chowdary P. Long-term efficacy and safety of subcutaneous concizumab prophylaxis in hemophilia A and hemophilia A/B with inhibitors. Blood Adv. 2022 Jun 14;6(11):3422-3432. doi: 10.1182/bloodadvances.2021006403.
PubMed 35290453Shapiro AD, Angchaisuksiri P, Astermark J, Benson G, Castaman G, Chowdary P, Eichler H, Jimenez-Yuste V, Kavakli K, Matsushita T, Poulsen LH, Wheeler AP, Young G, Zupancic-Salek S, Oldenburg J. Subcutaneous concizumab prophylaxis in hemophilia A and hemophilia A/B with inhibitors: phase 2 trial results. Blood. 2019 Nov 28;134(22):1973-1982. doi: 10.1182/blood.2019001542.
PubMed 31444162
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Randomised, Open-Label, Controlled Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors
- ClinicalTrials.gov ID
- NCT03196284
- Acronym / sponsor ID
- explorer™4 / NN7415-4310
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Posted 22 Oct 2021
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 Africa, Asia, Europe and North America. The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concizumab | Experimental | Drug: Concizumab, Drug: Eptacog alfaConcizumab administered in both the main phase and extension phase, with eptacog alfa administered on-demand during bleeding episodes |
| Eptacog alfa and concizumab | Active comparator | Drug: Concizumab, Drug: Eptacog alfaEptacog alfa administered on-demand during bleeding episodes as the only intervention during the main phase. Concizumab given in the extension phase |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| ConcizumabA loading dose of 0.5 mg/kg will be given as the first dose, followed by 0.15 mg/kg (with potential stepwise dose escalation to 0.25 mg/kg) administered daily s.c. (subcutaneously, under the skin). Treatment duration is 24 weeks in the main trial, and up to 52 weeks in the extension phase | Drug | Concizumab, Eptacog alfa and concizumab |
| Eptacog alfaA single dose of 90 μg/kg eptacog alfa one week after dosing with concizumab. On-demand treatment during bleeding episodes in both treatment arms | Drug | Concizumab, Eptacog alfa and concizumab |
Primary outcome
The Number of Bleeding Episodes
Time frame: During at least 24 weeks from treatment onset (week 0)
The number of bleeding episodes that were treated during at least 24 weeks from treatment onset (week 0) are presented.
30 secondary outcomes
The Number of Bleeding Episodes
Time frame: During at least 76 weeks from treatment onset (week 0)
The Number of Spontaneous Bleeding Episodes
Time frame: During at least 24 weeks from treatment onset (week 0)
The Number of Spontaneous Bleeding Episodes
Time frame: During at least 76 weeks from treatment onset (week 0)
Number of Treatment-emergent Adverse Events (TEAEs) During at Least 24 Weeks From Treatment Onset
Time frame: During at least 24 weeks from treatment onset (week 0)
Number of Treatment-emergent Adverse Events (TEAEs) During at Least 76 Weeks From Treatment Onset
Time frame: During at least 76 weeks from treatment onset (week 0)
Number of Treatment-emergent Adverse Events (TEAEs) Within 24 Hours After Eptacog Alfa Administration
Time frame: Within 24 hours after eptacog alfa administration
Occurrence of Anti-concizumab Antibodies During at Least 24 Weeks From Treatment Onset
Time frame: During at least 24 weeks from treatment onset (week 0)
Occurrence of Anti-concizumab Antibodies During at Least 76 Weeks From Treatment Onset
Time frame: During at least 76 weeks from treatment onset (week 0)
Change in Fibrinogen
Time frame: During at least 24 weeks from treatment onset (week 0)
Change in Fibrinogen
Time frame: During at least 76 weeks from treatment onset (week 0)
Change in D-dimer
Time frame: During at least 24 weeks from treatment onset (week 0)
Change in D-dimer
Time frame: During at least 76 weeks from treatment onset (week 0)
Change in Prothrombin Fragment 1 + 2 (F1 + 2)
Time frame: During at least 24 weeks from treatment onset (week 0)
Change in Prothrombin Fragment 1 + 2 (F1 + 2)
Time frame: During at least 76 weeks from treatment onset (week 0)
Change in Prothrombin Time (PT)
Time frame: During at least 24 weeks from treatment onset (week 0)
Change in Prothrombin Time (PT)
Time frame: During at least 76 weeks from treatment onset (week 0)
Change in Activated Partial Thromboplastin Time (APTT)
Time frame: During at least 24 weeks from treatment onset (week 0)
Change in Activated Partial Thromboplastin Time (APTT)
Time frame: During at least 76 weeks from treatment onset (week 0)
Change in Anti-thrombin (AT)
Time frame: During at least 24 weeks from treatment onset (week 0)
Change in Anti-thrombin (AT)
Time frame: After at least 76 weeks from treatment onset (week 0)
Concentration of Concizumab
Time frame: Prior to the last dose administration at 24 weeks
Concentration of Concizumab
Time frame: Prior to the last dose administration after atleast 76 weeks
Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value
Time frame: Prior to the last dose administration at 24 weeks
Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value
Time frame: Prior to the last dose administration after atleast 76 weeks
Peak Thrombin Generation
Time frame: Prior to the last dose administration at 24 weeks
Peak Thrombin Generation
Time frame: Prior to the last dose administration after atleast 76 weeks
Endogenous Thrombin Potential
Time frame: Prior to the last dose administration at 24 weeks
Endogenous Thrombin Potential
Time frame: Prior to the last dose administration after atleast 76 weeks
Thrombin Generation Velocity Index
Time frame: Prior to the last dose administration at 24 weeks
Thrombin Generation Velocity Index
Time frame: Prior to the last dose administration after atleast 76 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35290453Shapiro AD, Angchaisuksiri P, Astermark J, Benson G, Castaman G, Eichler H, Jimenez-Yuste V, Kavakli K, Matsushita T, Poulsen LH, Wheeler AP, Young G, Zupancic-Salek S, Oldenburg J, Chowdary P. Long-term efficacy and safety of subcutaneous concizumab prophylaxis in hemophilia A and hemophilia A/B with inhibitors. Blood Adv. 2022 Jun 14;6(11):3422-3432. doi: 10.1182/bloodadvances.2021006403.
- Derived from this study: PubMed 31444162Shapiro AD, Angchaisuksiri P, Astermark J, Benson G, Castaman G, Chowdary P, Eichler H, Jimenez-Yuste V, Kavakli K, Matsushita T, Poulsen LH, Wheeler AP, Young G, Zupancic-Salek S, Oldenburg J. Subcutaneous concizumab prophylaxis in hemophilia A and hemophilia A/B with inhibitors: phase 2 trial results. Blood. 2019 Nov 28;134(22):1973-1982. doi: 10.1182/blood.2019001542.
- Individual participant dataSharing planned: Yes. According to disclosure commitment on novonordisk-trials.com
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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.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Concizumab and Eptacog alfa in people with Congenital Bleeding Disorder and Haemophilia A With Inhibitors, run by Novo Nordisk A/S at 22 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Japan, Italy, Malaysia, Spain and 9 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Bleeding Episodes (time frame: During at least 24 weeks from treatment onset (week 0)). 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 NCT03196284, which also lists 2 linked publications.
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 22 Oct 2021.