A Phase 3 interventional study of Concizumab in Haemophilia A and B With and Without Inhibitors, sponsored by Novo Nordisk A/S. Active, not recruiting at 91 sites in 24 countries. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This study will test how well a new medicine called concizumab works for participants who have haemophilia A or B with or without inhibitors. The purpose is to show that concizumab can prevent bleeds and is safe to use.
Participants will have to inject the study medicine every day under the skin with a pen-injector.
The study will last for at least 2 years and up to about 4 years. The length of time the participant will be in the study depends on if the study medicine will be available for purchase in their country.
844 studies on the registry are indexed under Hemophilia A; 138 are open to participants now.
This study's planned enrollment of 153 is above the median of 30 across 499 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →Novo Nordisk A/S is the lead sponsor of 1,404 studies on the registry; 101 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For arm 1 only: Patients with inhibitors (haemophilia A with inhibitors or haemophilia B with inhibitors)
For arm 1 only: Patients without inhibitors (haemophilia A or haemophilia B)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Concizumab-naïve participants below 12 years of age at the time of consent/assent
Drug: Concizumab
Patients previously treated with concizumab via compassionate use, either on an individual patient basis or through the concizumab compassionate use programme NN7415-4807
Drug: Concizumab
Participants in Arm 1 will be assigned to concizumab prophylaxis starting with a loading dose on treatment day 0 followed by daily injections of an individual maintenance dose. Participants in Arm 2 will be assigned to concizumab prophylaxis with daily injections of an individual maintenance dose.
For inhibitor patients with at least 26 weeks on-demand treatment during the last 52 weeks prior enrolment: Number of treated spontaneous and traumatic bleeding episodes
Count of episode(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
For non-inhibitor patients treated on demand during at least the last 52 weeks prior enrolment: Number of treated spontaneous and traumatic bleeding episodes
Count of episode(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
For inhibitor patients with at least 26 weeks on-demand treatment during the last 52 weeks prior enrolment: Number of all bleeding episodes (spontaneous and traumatic)
Count of episode(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
For inhibitor patients with at least 26 weeks on-demand treatment during the last 52 weeks prior enrolment: Number of treated spontaneous bleeding episodes
Count of episode(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
For inhibitor patients with at least 26 weeks on-demand treatment during the last 52 weeks prior enrolment: Number of treated joint bleeding episodes
Count of episode(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
For inhibitor patients with at least 26 weeks on-demand treatment during the last 52 weeks prior enrolment: Number of treated bleeding episodes in baseline target joints
Count of episode(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
For non-inhibitor patients treated on-demand during at least the last 52 weeks prior enrolment: Number of all bleeding episodes (spontaneous and traumatic)
Count of episode(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
For non-inhibitor patients treated on-demand during at least the last 52 weeks prior enrolment: Number of treated spontaneous bleeding episodes
Count of episode(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
For non-inhibitor patients treated on-demand at least the last 52 weeks prior enrolment: Number of treated joint bleeding episodes
Count of episode(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
For non-inhibitor patients treated on-demand at least the last 52 weeks prior enrolment: Number of treated bleeding episodes in baseline target joints
Count of episode(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
For non-inhibitor patients with at least 26 weeks PPX treatment during the last 52 weeks prior enrolment: Number of treated spontaneous and traumatic bleeding episodes
Count of episode(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
For non-inhibitor patients with at least 26 weeks PPX treatment during the last 52 weeks prior enrolment: Number of all bleeding episodes (spontaneous and traumatic)
Count of episode(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
For non-inhibitor patients with at least 26 weeks PPX treatment during the last 52 weeks prior enrolment: Number of treated spontaneous bleeding episodes
Count of episode(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
For non-inhibitor patients with at least 26 weeks PPX treatment during the last 52 weeks prior enrolment: Number of treated joint bleeding episodes
Count of episode(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
For non-inhibitor patients with at least 26 weeks PPX treatment during the last 52 weeks prior enrolment: Number of treated bleeding episodes in baseline target joints
Count of episode(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
Concizumab-naïve pateints - Number of treatment emergent adverse events, reported both separately for inhibitor and non-inhibitor patients and combined
Count of event(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
Number of thromboembolic events, reported both separately for inhibitor and non-inhibitor patients and combined
Count of event(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
Number of hypersensitivity type reactions, reported both separately for inhibitor and non-inhibitor patients and combined
Count of event(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
Number of injection site reactions, reported both separately for inhibitor and non-inhibitor patients and combined
Count of event(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
Number of patients who develop antibodies to concizumab - yes/no, reported both separately for inhibitor and non-inhibitor patients and combined
Count of patient(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
Number of treatment emergent adverse events, reported both separately for inhibitor and non-inhibitor patients and combined
Count of event(s)
Time frame: From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)
Concizumab plasma concentrations prior to dosing, reported both separately for inhibitor and non-inhibitor patients and combined
Measured in ng/mL
Time frame: Week 32
Peak thrombin generation prior to dosing, reported both separately for inhibitor and non-inhibitor patients and combined
Measured in nM
Time frame: Week 32
Free TFPI concentration prior to dosing, reported both separately for inhibitor and non-inhibitor patients and combined
Measured in ng/mL
Time frame: Week 32
Pre-dose (trough) concizumab plasma concentration (Ctrough), reported both separately for inhibitor and non-inhibitor patients and combined
Measured in ng/mL
Time frame: Prior to the concizumab administration at week 20
Maximum concizumab plasma concentration (Cmax), reported both separately for inhibitor and non-inhibitor patients and combined
Measured in ng/mL
Time frame: From 0 to 24 hours where 0 is the time of the concizumab dose at week 20
Area under the concizumab plasma concentration-time curve (AUC), reported both separately for inhibitor and non-inhibitor patients and combined
Measured in ng\*hr/mL
Time frame: From 0 to 24 hours where 0 is the time of the concizumab dose at week 20
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Data sharing details ↗ · novonordisk-trials.com
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Concizumab