A Phase 3 interventional study of Concizumab in Haemophilia A Without Inhibitors and Haemophilia B Without Inhibitors, sponsored by Novo Nordisk A/S. Active, not recruiting at 113 sites in 33 countries. Open to male participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B without inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use. Participants who usually only take medicine to treat bleeds (on-demand) will be placed in one of two groups. In one group participants will get study medicine from the start of the study. In the other group participants will continue with their normal medicine and get study medicine after 6 months. Which treatment the participant gets is decided by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment) or who are already being treated with concizumab (study medicine) will receive the study medicine from the start of the study. Participants will have to inject themselves with the study medicine 1 time every day under the skin. This can be done at home. The study doctor will hand out the medicine in the form of a pen-injector. The pen-injector will contain the study medicine. The study will last for up to 8 years. The length of time the participant will be in the study depends on when they agreed to take part and when the medicine is available for purchase in their country (or 31 December 2027 at the latest). The time between visits will be approximately 4 weeks for the first 6 to 12 months depending on the group participants are in, and approximately 8 weeks for the rest of the study. If the participant attends extra visits due to the prescription medicine not being available for purchase in their country, these will be 14 weeks apart. Participants will be asked to record information in an electronic diary during the study and may also be asked to wear an activity tracker.
844 studies on the registry are indexed under Hemophilia A; 138 are open to participants now.
This study's enrollment of 156 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.
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.
Haemophilia A (HA) and haemophilia B (HB) patients, previously treated on-demand, will be randomised 1:2 to no prophylaxis versus concizumab prophylaxis. In the extension phase, this group will receive treatment with concizumab.
Drug: Concizumab
HA and HB patients, previously treated on-demand, will be randomised 1:2 to no prophylaxis versus concizumab prophylaxis.
Drug: Concizumab
The HA patients enrolled into the concizumab phase 2 trial NN7415-4255 (explorer 5) will be offered enrolment into this arm.
Drug: Concizumab
Arm 4 will include patients previously on prophylaxis with factor products with a minimum of 24 weeks observation in NN7415-4322 (explorer 6) (at least 30 HA and 30 HB patients). In addition, arm 4 will also include: 1) Patients who were randomised to arms 1 and 2 before the treatment pause. 2) HA patients who were in NN7415-4255 (explorer 5) at the time of the treatment pause, and who have now completed explorer 5. 3) On demand patients included after arms 1 and 2 are closed.
Drug: Concizumab
When patients are randomised/allocated to concizumab prophylaxis, they will receive a loading dose of 1.0 mg/kg concizumab at visit 2a (week (Wk) 0) (arm 2, 3 and 4) or visit 9a (Wk 24) (arm 1) followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week dose adjustment period on 0.20 mg/kg concizumab, the patients can be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab. A potential dose adjustment will take place at visit 4a.1 (Wk 6) or 9a.3 (Wk 30) and will be based on the concizumab exposure level measured at the previous visit 4a (Wk 6) or 9a.2 (Wk 28). Patients who have concizumab exposure levels of 200-4000 ng/mL will stay at 0.20 mg/kg concizumab. Patients in arm 1 will continue on-demand treatment with their usual replacement therapy until visit 9a (week 24; end of main part). In the extension part, patients in arm 1 will receive daily concizumab subcutaneous injections.
Haemophilia A Participants Without Inhibitors: Rate of Treated Spontaneous and Traumatic Bleeding Episodes
Rate of treated spontaneous and traumatic bleeding episodes for haemophilia A participants without inhibitors is presented. The observation period used for reporting this endpoint is on-treatment without ancillary therapy excluding data before restart (OTwoATexBR). It is defined as the time period after the restart where participants are treated by concizumab treatment or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleeding episode. The data is reported in the terms of annualised bleeding rate (ABR). Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen. Confirmatory analyses cut-off was defined as when all participants on no PPX (arm 1) had completed the 24-week visit or withdrawn and all participants on concizumab PPX (in arms 2 and 4) had completed the 32-week visit or withdrawn.
Time frame: On demand (arm 1): From week 0 up until start of concizumab treatment (week 24); Concizumab (arm 2): From week 0 up until the confirmatory analyses cut-off
Haemophilia B Participants Without Inhibitors: Rate of Treated Spontaneous and Traumatic Bleeding Episodes
Rate of treated spontaneous and traumatic bleeding episodes for haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OTwoATexBR. It is defined as the time period after the restart where participants are treated by concizumab treatment or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleeding episode. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen. Confirmatory analyses cut-off was defined as when all participants on no PPX (arm 1) had completed the 24-week visit or withdrawn and all participants on concizumab PPX (in arms 2 and 4) had completed the 32-week visit or withdrawn.
Time frame: On demand (arm 1): From week 0 up until start of concizumab treatment (week 24); Concizumab (arm 2): From week 0 up until the confirmatory analyses cut-off
Haemophilia A Participants Without Inhibitors: Rate of Treated Spontaneous and Traumatic Bleeding Episodes
Rate of treated spontaneous and traumatic bleeding episodes for haemophilia A participants without inhibitors in arm 4 participants who had been on stable PPX at least 24 weeks in study 4322 is presented. The observation period used for reporting this endpoint is on stable treatment without ancillary therapy excluding data before restart (OT stable woATexBR). It is defined as the time period where participants are on stable PPX in study NN7415-4322 combined with the time period after the treatment pause in NN7415-4307 where the same participants are on the maintenance dose and have not used factor-containing products not related to treatment of a bleed. The data is reported in the terms of ABR.
Time frame: For previous PPX (study 4322): After an initial period on PPX treatment of at least 24 weeks until end of study (maximum 115 weeks) For concizumab PPX (trial 4307): After an initial 5-8 weeks dose adjustment period and up until 56 week cut off
Haemophilia B Participants Without Inhibitors: Rate of Treated Spontaneous and Traumatic Bleeding Episodes
Rate of treated spontaneous and traumatic bleeding episodes for haemophilia B participants without inhibitors in arm 4 participants who had been on stable PPX at least 24 weeks in study 4322 is presented. The observation period used for reporting this endpoint is OT stable woATexBR. It is defined as the time period where participants are on stable PPX in study NN7415-4322 combined with the time period after the treatment pause in NN7415-4307 where the same participants are on the maintenance dose and have not used factor-containing products not related to treatment of a bleed. The data is reported in the terms of ABR.
Time frame: For previous PPX (study 4322): After an initial period on PPX treatment of at least 24 weeks until end of study (maximum 115 weeks) For concizumab PPX (trial 4307): After an initial 5-8 weeks dose adjustment period and up until 56 week cut off
Haemophilia A Participants Without Inhibitors: Rate of Treated Spontaneous Bleeding Episodes
Rate of treated spontaneous bleeding episodes for haemophilia A participants without inhibitors is presented. The observation period used for reporting this endpoint is OTwoATexBR. It is defined as the time period after the restart where participants are treated by concizumab treatment or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleeding episode. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.
Time frame: On demand (arm 1): From randomisation after the pause (week 0) up until start of concizumab treatment (week 24) Concizumab (arm 2): From start of the new concizumab dosing regimen (week 0) up until the 56 week cut-off
Haemophilia B Participants Without Inhibitors: Rate of Treated Spontaneous Bleeding Episodes
Rate of treated spontaneous bleeding episodes for haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OTwoATexBR. It is defined as the time period after the restart where participants are treated by concizumab treatment or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleeding episode. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.
Time frame: On demand (arm 1): From randomisation after the pause (week 0) up until start of concizumab treatment (week 24) Concizumab (arm 2): From start of the new concizumab dosing regimen (week 0) up until the 56 week cut-off
Haemophilia A Participants Without Inhibitors: Rate of Treated Spontaneous and Traumatic Joint Bleeding Episodes
Rate of treated spontaneous and traumatic joint bleeding episodes for haemophilia A participants without inhibitors is presented. The observation period used for reporting this endpoint is OTwoATexBR. It is defined as the time period after the restart where participants are treated by concizumab treatment or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleeding episode. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.
Time frame: On demand (arm 1): From randomisation after the pause (week 0) up until start of concizumab treatment (week 24) Concizumab (arm 2): From start of the new concizumab dosing regimen (week 0) up until the 56 week cut-off
Haemophilia B Participants Without Inhibitors: Rate of Treated Spontaneous and Traumatic Joint Bleeding Episodes
Rate of treated spontaneous and traumatic joint bleeding episodes for haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OTwoATexBR. It is defined as the time period after the restart where participants are treated by concizumab treatment or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleeding episode. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.
Time frame: On demand (arm 1): From randomisation after the pause (week 0) up until start of concizumab treatment (week 24) Concizumab (arm 2): From start of the new concizumab dosing regimen (week 0) up until the 56 week cut-off
Haemophilia A Participants Without Inhibitors: Rate of Treated Spontaneous and Traumatic Target Joint Bleeding Episodes
Rate of treated spontaneous and traumatic target joint bleeding episodes for haemophilia A participants without inhibitors is presented. The observation period used for reporting this endpoint is OTwoATexBR. It is defined as the time period after the restart where participants are treated by concizumab treatment or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleeding episode. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.
Time frame: On demand (arm 1): From randomisation after the pause (week 0) up until start of concizumab treatment (week 24) Concizumab (arm 2): From start of the new concizumab dosing regimen (week 0) up until the 56 week cut-off
Haemophilia B Participants Without Inhibitors: Rate of Treated Spontaneous and Traumatic Target Joint Bleeding Episodes
Rate of treated spontaneous and traumatic target joint bleeding episodes for haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OTwoATexBR. It is defined as the time period after the restart where participants are treated by concizumab treatment or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleeding episode. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.
Time frame: On demand (arm 1): From randomisation after the pause (week 0) up until start of concizumab treatment (week 24) Concizumab (arm 2): From start of the new concizumab dosing regimen (week 0) up until the 56 week cut-off
Haemophila A and Haemophilia B Participants Without Inhibitors: Number of Thromboembolic Events
Number of thromboembolic events in haemophilia A and haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is on-treatment (OT). It is defined as the time period where participants were considered to be affected by no PPX (on-demand treatment) or concizumab PPX. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.
Time frame: On demand (arm 1): from week 0 until start of concizumab treatment (week 24). Concizumab (arms 2-4): From week 0 up until the 56 week cut-off. Concizumab (arm 1 extension part): From start of concizumab treatment (week 25) up until the 56 week cut-off
Haemophila A and Haemophilia B Participants Without Inhibitors: Number of Thromboembolic Events
Time frame: From week 0 to end of trial (up to 384 weeks)
Haemophila A and Haemophilia B Participants Without Inhibitors: Number of Hypersensitivity Type Reactions
Number of hypersensitivity type reactions in haemophilia A and haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OT. It is defined as the time period where participants were considered to be affected by no PPX (on-demand treatment) or concizumab PPX. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.
Time frame: On demand (arm 1): from week 0 until start of concizumab treatment (week 24). Concizumab (arms 2-4): From week 0 up until the 56 week cut-off. Concizumab (arm 1 extension part): From start of concizumab treatment (week 25) up until the 56 week cut-off
Haemophila A and Haemophilia B Participants Without Inhibitors: Number of Hypersensitivity Type Reactions
Time frame: From week 0 to end of trial (up until 384 weeks)
Haemophila A and Haemophilia B Participants Without Inhibitors: Number of Injection Site Reactions
Number of injection site reactions in haemophilia A and haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OT. It is defined as the time period where participants were considered to be affected by no PPX (on-demand treatment) or concizumab PPX. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.
Time frame: On demand (arm 1 main part): from randomisation (week 0) until start of concizumab treatment (week 24). Concizumab (arms 2-4): From week 0 up until the 56 week cut-off. Concizumab (arm 1 extension part): From week 25 up until the 56 week cut-off
Haemophila A and Haemophilia B Participants Without Inhibitors: Number of Injection Site Reactions
Time frame: From week 0 to end of trial (up until 384 weeks)
Haemophila A and Haemophilia B Participants Without Inhibitors: Number of Participants With Antibodies to Concizumab
Time frame: Concizumab (arms 2-4): From start of concizumab treatment (week 0) up until the 56 week cut-off. Concizumab (arm 1 extension part): From start of concizumab treatment (week 25) up until the 56 week cut-off
Haemophila A and Haemophilia B Participants Without Inhibitors: Number of Participants With Antibodies to Concizumab
Time frame: From week 0 to end of trial (up until 384 weeks)
Haemophila A and Haemophilia B Participants Without Inhibitors: Pre-dose (Trough) Concizumab Plasma Concentration (Ctrough)
Ctrough for haemophilia A and haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is on-treatment without data before re-start (OTexBR). It is defined as the time period after restart where participants were considered to be affected by no PPX (on-demand treatment) or treatment with the new concizumab regimen.
Time frame: Pre-dose (prior to the concizumab administration at week 24)
Haemophila A and Haemophilia B Participants Without Inhibitors: Pre-dose Thrombin Peak
Pre-dose thrombin peak for haemophilia A and haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OTexBR. It is defined as the time period after restart where participants were considered to be affected by no PPX (on-demand treatment) or treatment with the new concizumab regimen.
Time frame: Pre-dose (prior to the concizumab administration at week 24)
Haemophila A and Haemophilia B Participants Without Inhibitors: Pre-dose Free Tissue Factor Pathway Inhibitor (TFPI) Concentration
Pre-dose free TFPI for haemophilia A and haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OTexBR. It is defined as the time period after restart where participants were considered to be affected by no PPX (on-demand treatment) or treatment with the new concizumab regimen.
Time frame: Pre-dose (prior to the concizumab administration at week 24)
Haemophila A and Haemophilia B Participants Without Inhibitors: Maximum Concizumab Plasma Concentration (Cmax)
Cmax for haemophilia A and haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OTexBR. It is defined as the time period after restart where participants were considered to be affected by no PPX (on-demand treatment) or treatment with the new concizumab regimen.
Time frame: Pre-dose, Week 24: 3 hours (h), 6h, 9h, 24h
Haemophila A and Haemophilia B Participants Without Inhibitors: Area Under the Concizumab Plasma Concentration-time Curve (AUC)
AUC for haemophilia A and haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OTexBR. It is defined as the time period after restart where participants were considered to be affected by no PPX (on-demand treatment) or treatment with the new concizumab regimen.
Time frame: Pre-dose, Week 24: 3 hours (h), 6h, 9h, 24h
The trial was conducted at 68 sites in 31 countries.
| Milestone | Arm 1: Previous On Demand (OnD) Treatment: No Prophylaxis (PPX) - Participants With HA | Extension Phase Arm 1: Concizumab PPX - Participants With HA | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HA | Arm 3: Concizumab Non-naive: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX - Participants With HA | Arm 1: Previous OnD Treatment: No PPX - Participants With HB | Extension Phase Arm 1: Concizumab PPX - Participants With HB | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB | Arm 4: Concizumab PPX - Participants With HB |
|---|---|---|---|---|---|---|---|---|---|
| Started | 1 | 0 | 3 | 10 | 18 | 1 | 0 | 2 | 2 |
| Completed | 0 | 0 | 2 | 9 | 13 | 1 | 0 | 2 | 2 |
| Not completed | 1 | 0 | 1 | 1 | 5 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 1 | 1 | 3 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Milestone | Arm 1: Previous On Demand (OnD) Treatment: No Prophylaxis (PPX) - Participants With HA | Extension Phase Arm 1: Concizumab PPX - Participants With HA | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HA | Arm 3: Concizumab Non-naive: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX - Participants With HA | Arm 1: Previous OnD Treatment: No PPX - Participants With HB | Extension Phase Arm 1: Concizumab PPX - Participants With HB | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB | Arm 4: Concizumab PPX - Participants With HB |
|---|---|---|---|---|---|---|---|---|---|
| Started | 9 | 0 | 18 | 9 | 46 | 12 | 0 | 24 | 30 |
| Completed | 7 | 0 | 17 | 6 | 45 | 10 | 0 | 23 | 25 |
| Not completed | 2 | 0 | 1 | 3 | 1 | 2 | 0 | 1 | 5 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 5 |
| Withdrew: Unspecified reason | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Milestone | Arm 1: Previous On Demand (OnD) Treatment: No Prophylaxis (PPX) - Participants With HA | Extension Phase Arm 1: Concizumab PPX - Participants With HA | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HA | Arm 3: Concizumab Non-naive: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX - Participants With HA | Arm 1: Previous OnD Treatment: No PPX - Participants With HB | Extension Phase Arm 1: Concizumab PPX - Participants With HB | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB | Arm 4: Concizumab PPX - Participants With HB |
|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 7 | 17 | 6 | 45 | 0 | 10 | 23 | 25 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 7 | 17 | 6 | 45 | 0 | 10 | 23 | 25 |
| Withdrew: Ongoing | 0 | 7 | 17 | 6 | 45 | 0 | 10 | 23 | 25 |
Rate of treated spontaneous and traumatic bleeding episodes for haemophilia A participants without inhibitors is presented. The observation period used for reporting this endpoint is on-treatment without ancillary therapy excluding data before restart (OTwoATexBR). It is defined as the time period after the restart where participants are treated by concizumab treatment or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleeding episode. The data is reported in the terms of annualised bleeding rate (ABR). Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen. Confirmatory analyses cut-off was defined as when all participants on no PPX (arm 1) had completed the 24-week visit or withdrawn and all participants on concizumab PPX (in arms 2 and 4) had completed the 32-week visit or withdrawn.
| Events per year | Arm 1: Previous On Demand (OnD) Treatment: No Prophylaxis (PPX) - Participants With HA | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HA |
|---|---|---|
| Haemophilia A Participants Without Inhibitors: Rate of Treated Spontaneous and Traumatic Bleeding Episodes | 19.6 (17.3 to 30.4) | 2.9 (0.0 to 5.2) |
Rate of treated spontaneous and traumatic bleeding episodes for haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OTwoATexBR. It is defined as the time period after the restart where participants are treated by concizumab treatment or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleeding episode. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen. Confirmatory analyses cut-off was defined as when all participants on no PPX (arm 1) had completed the 24-week visit or withdrawn and all participants on concizumab PPX (in arms 2 and 4) had completed the 32-week visit or withdrawn.
| Events per year | Arm 1: Previous OnD Treatment: No PPX - Participants With HB | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB |
|---|---|---|
| Haemophilia B Participants Without Inhibitors: Rate of Treated Spontaneous and Traumatic Bleeding Episodes | 14.9 (3.3 to 22.1) | 1.6 (0.0 to 4.8) |
Rate of treated spontaneous and traumatic bleeding episodes for haemophilia A participants without inhibitors in arm 4 participants who had been on stable PPX at least 24 weeks in study 4322 is presented. The observation period used for reporting this endpoint is on stable treatment without ancillary therapy excluding data before restart (OT stable woATexBR). It is defined as the time period where participants are on stable PPX in study NN7415-4322 combined with the time period after the treatment pause in NN7415-4307 where the same participants are on the maintenance dose and have not used factor-containing products not related to treatment of a bleed. The data is reported in the terms of ABR.
| Events per year | Arm 4: Previous PPX (Study 4322) - Participants With HA | Arm 4: Concizumab PPX (Study 4307) - Participants With HA |
|---|---|---|
| Haemophilia A Participants Without Inhibitors: Rate of Treated Spontaneous and Traumatic Bleeding Episodes | 2.2 (0.8 to 6.2) | 1.7 (0.5 to 4.8) |
Rate of treated spontaneous and traumatic bleeding episodes for haemophilia B participants without inhibitors in arm 4 participants who had been on stable PPX at least 24 weeks in study 4322 is presented. The observation period used for reporting this endpoint is OT stable woATexBR. It is defined as the time period where participants are on stable PPX in study NN7415-4322 combined with the time period after the treatment pause in NN7415-4307 where the same participants are on the maintenance dose and have not used factor-containing products not related to treatment of a bleed. The data is reported in the terms of ABR.
| Events per year | Arm 4: Previous PPX (Study 4322) - Participants With HB | Arm 4: Concizumab PPX (Study 4307) - Participants With HA |
|---|---|---|
| Haemophilia B Participants Without Inhibitors: Rate of Treated Spontaneous and Traumatic Bleeding Episodes | 2.1 (0.9 to 4.2) | 1.3 (0.0 to 6.4) |
Rate of treated spontaneous bleeding episodes for haemophilia A participants without inhibitors is presented. The observation period used for reporting this endpoint is OTwoATexBR. It is defined as the time period after the restart where participants are treated by concizumab treatment or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleeding episode. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.
| Events per year | Arm 1: Previous On Demand (OnD) Treatment: No Prophylaxis (PPX) - Participants With HA | Arm 2: Concizumab PPX - Participants With HA |
|---|---|---|
| Haemophilia A Participants Without Inhibitors: Rate of Treated Spontaneous Bleeding Episodes | 19.3 (7.2 to 20.5) | 1.0 (0.0 to 3.6) |
Rate of treated spontaneous bleeding episodes for haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OTwoATexBR. It is defined as the time period after the restart where participants are treated by concizumab treatment or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleeding episode. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.
| Events per year | Arm 1: Previous OnD Treatment: No PPX - Participants With HB | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB |
|---|---|---|
| Haemophilia B Participants Without Inhibitors: Rate of Treated Spontaneous Bleeding Episodes | 10.8 (3.3 to 17.8) | 1.0 (0.0 to 2.5) |
Rate of treated spontaneous and traumatic joint bleeding episodes for haemophilia A participants without inhibitors is presented. The observation period used for reporting this endpoint is OTwoATexBR. It is defined as the time period after the restart where participants are treated by concizumab treatment or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleeding episode. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.
| Events per year | Arm 1: Previous On Demand (OnD) Treatment: No Prophylaxis (PPX) - Participants With HA | Arm 2: Concizumab PPX - Participants With HA |
|---|---|---|
| Haemophilia A Participants Without Inhibitors: Rate of Treated Spontaneous and Traumatic Joint Bleeding Episodes | 13.0 (10.7 to 28.3) | 2.0 (0.0 to 4.0) |
Rate of treated spontaneous and traumatic joint bleeding episodes for haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OTwoATexBR. It is defined as the time period after the restart where participants are treated by concizumab treatment or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleeding episode. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.
| Events per year | Arm 1: Previous OnD Treatment: No PPX - Participants With HB | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB |
|---|---|---|
| Haemophilia B Participants Without Inhibitors: Rate of Treated Spontaneous and Traumatic Joint Bleeding Episodes | 10.0 (3.3 to 18.0) | 2.0 (0.0 to 3.7) |
Rate of treated spontaneous and traumatic target joint bleeding episodes for haemophilia A participants without inhibitors is presented. The observation period used for reporting this endpoint is OTwoATexBR. It is defined as the time period after the restart where participants are treated by concizumab treatment or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleeding episode. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.
| Events per year | Arm 1: Previous On Demand (OnD) Treatment: No Prophylaxis (PPX) - Participants With HA | Arm 2: Concizumab PPX - Participants With HA |
|---|---|---|
| Haemophilia A Participants Without Inhibitors: Rate of Treated Spontaneous and Traumatic Target Joint Bleeding Episodes | 4.3 (1.6 to 13.0) | 1.7 (0.0 to 3.0) |
Rate of treated spontaneous and traumatic target joint bleeding episodes for haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OTwoATexBR. It is defined as the time period after the restart where participants are treated by concizumab treatment or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleeding episode. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.
| Events per year | Arm 1: Previous OnD Treatment: No PPX - Participants With HB | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB |
|---|---|---|
| Haemophilia B Participants Without Inhibitors: Rate of Treated Spontaneous and Traumatic Target Joint Bleeding Episodes | 2.2 (0.0 to 8.1) | 0.7 (0.0 to 1.5) |
Number of thromboembolic events in haemophilia A and haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is on-treatment (OT). It is defined as the time period where participants were considered to be affected by no PPX (on-demand treatment) or concizumab PPX. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.
| Events | Arm 1: Previous On Demand (OnD) Treatment: No Prophylaxis (PPX) - Participants With HA | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HA | Arm 3: Concizumab Non-naive: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX - Participants With HA | Extension Phase Arm 1: Concizumab PPX - Participants With HA | Arm 1: Previous OnD Treatment: No PPX - Participants With HB | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB | Arm 4: Concizumab PPX - Participants With HB | Extension Phase Arm 1: Concizumab PPX - Participants With HB |
|---|---|---|---|---|---|---|---|---|---|
| Haemophila A and Haemophilia B Participants Without Inhibitors: Number of Thromboembolic Events | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 |
Results for this outcome have not been posted.
Number of hypersensitivity type reactions in haemophilia A and haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OT. It is defined as the time period where participants were considered to be affected by no PPX (on-demand treatment) or concizumab PPX. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.
| Reactions | Arm 1: Previous On Demand (OnD) Treatment: No Prophylaxis (PPX) - Participants With HA | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HA | Arm 3: Concizumab Non-naive: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX - Participants With HA | Extension Phase Arm 1: Concizumab PPX - Participants With HA | Arm 1: Previous OnD Treatment: No PPX - Participants With HB | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB | Arm 4: Concizumab PPX - Participants With HB | Extension Phase Arm 1: Concizumab PPX - Participants With HB |
|---|---|---|---|---|---|---|---|---|---|
| Haemophila A and Haemophilia B Participants Without Inhibitors: Number of Hypersensitivity Type Reactions | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Results for this outcome have not been posted.
Number of injection site reactions in haemophilia A and haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OT. It is defined as the time period where participants were considered to be affected by no PPX (on-demand treatment) or concizumab PPX. Week 0 is defined as time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.
| Reactions | Arm 1: Previous On Demand (OnD) Treatment: No Prophylaxis (PPX) - Participants With HA | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HA | Arm 3: Concizumab Non-naive: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX - Participants With HA | Extension Phase Arm 1: Concizumab PPX - Participants With HA | Arm 1: Previous OnD Treatment: No PPX - Participants With HB | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB | Arm 4: Concizumab PPX - Participants With HB | Extension Phase Arm 1: Concizumab PPX - Participants With HB |
|---|---|---|---|---|---|---|---|---|---|
| Haemophila A and Haemophilia B Participants Without Inhibitors: Number of Injection Site Reactions | 0 | 1 | 0 | 14 | 1 | 0 | 2 | 28 | 0 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Ctrough for haemophilia A and haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is on-treatment without data before re-start (OTexBR). It is defined as the time period after restart where participants were considered to be affected by no PPX (on-demand treatment) or treatment with the new concizumab regimen.
| nanograms per milliliter (ng/mL) | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HA | Arm 3: Concizumab Non-naive: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX (IPAS) + Concizumab PPX (Others) - Participants With HA | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB | Arm 4: Concizumab PPX (IPAS) + Concizumab PPX (Others) - Participants With HB |
|---|---|---|---|---|---|
| Haemophila A and Haemophilia B Participants Without Inhibitors: Pre-dose (Trough) Concizumab Plasma Concentration (Ctrough) | 767.7 ± 112.4 | 612.3 ± 274.9 | 729.3 ± 158.6 | 413.6 ± 234.7 | 719.7 ± 189.7 |
Pre-dose thrombin peak for haemophilia A and haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OTexBR. It is defined as the time period after restart where participants were considered to be affected by no PPX (on-demand treatment) or treatment with the new concizumab regimen.
| nanomoles per liter (nmol/L) | Arm 1: Previous On Demand (OnD) Treatment: No Prophylaxis (PPX) - Participants With HA | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HA | Arm 3: Concizumab Non-naive: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX (IPAS) + Concizumab PPX (Others) - Participants With HA | Arm 1: Previous OnD Treatment: No PPX - Participants With HB | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB | Arm 4: Concizumab PPX (IPAS) + Concizumab PPX (Others) - Participants With HB |
|---|---|---|---|---|---|---|---|
| Haemophila A and Haemophilia B Participants Without Inhibitors: Pre-dose Thrombin Peak | 19.9 ± 117.7 | 98.3 ± 53.3 | 92.3 ± 69.0 | 92.1 ± 57.8 | 9.6 ± 110.7 | 54.6 ± 111.9 | 79.4 ± 57.1 |
Pre-dose free TFPI for haemophilia A and haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OTexBR. It is defined as the time period after restart where participants were considered to be affected by no PPX (on-demand treatment) or treatment with the new concizumab regimen.
| ng/mL | Arm 1: Previous On Demand (OnD) Treatment: No Prophylaxis (PPX) - Participants With HA | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HA | Arm 3: Concizumab Non-naive: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX (IPAS) + Concizumab PPX (Others) - Participants With HA | Arm 1: Previous OnD Treatment: No PPX - Participants With HB | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB | Arm 4: Concizumab PPX (IPAS) + Concizumab PPX (Others) - Participants With HB |
|---|---|---|---|---|---|---|---|
| Haemophila A and Haemophilia B Participants Without Inhibitors: Pre-dose Free Tissue Factor Pathway Inhibitor (TFPI) Concentration | 70.1 ± 12.3 | 11.1 ± 74.8 | 15.9 ± 75.8 | 9.6 ± 87.9 | 88.1 ± 14.6 | 16.3 ± 130.3 | 10.5 ± 107.4 |
Cmax for haemophilia A and haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OTexBR. It is defined as the time period after restart where participants were considered to be affected by no PPX (on-demand treatment) or treatment with the new concizumab regimen.
| ng/mL | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HA | Arm 3: Concizumab Non-naive: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX (IPAS) + Concizumab PPX (Others) - Participants With HA | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB | Arm 4: Concizumab PPX (IPAS) + Concizumab PPX (Others) - Participants With HB |
|---|---|---|---|---|---|
| Haemophila A and Haemophilia B Participants Without Inhibitors: Maximum Concizumab Plasma Concentration (Cmax) | 1158.2 ± 61.9 | 583.4 ± 282.2 | 1029.7 ± 130.9 | 689.2 ± 190.5 | 828.0 ± 111.2 |
AUC for haemophilia A and haemophilia B participants without inhibitors is presented. The observation period used for reporting this endpoint is OTexBR. It is defined as the time period after restart where participants were considered to be affected by no PPX (on-demand treatment) or treatment with the new concizumab regimen.
| nanograms*hour/milliliter (ng*hr/mL) | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HA | Arm 3: Concizumab Non-naive: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX (IPAS) + Concizumab PPX (Others) - Participants With HA | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB | Arm 4: Concizumab PPX (IPAS) + Concizumab PPX (Others) - Participants With HB |
|---|---|---|---|---|---|
| Haemophila A and Haemophilia B Participants Without Inhibitors: Area Under the Concizumab Plasma Concentration-time Curve (AUC) | 23582.5 ± 68.2 | 11082.7 ± 268.0 | 20355.6 ± 135.2 | 13020.5 ± 182.7 | 16191.8 ± 118.2 |
Collected over Up to week 56 cut-off. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: Previous On Demand (OnD) Treatment: No Prophylaxis (PPX) - Participants With HA | 0/9 (0%) | 0/9 (0%) | 2/9 (22.2%) |
| Extension Phase Arm 1: Concizumab PPX - Participants With HA | 0/7 (0%) | 0/7 (0%) | 5/7 (71.4%) |
| Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HA | 0/18 (0%) | 1/18 (5.6%) | 10/18 (55.6%) |
| Arm 3: Concizumab Non-naive: Concizumab PPX - Participants With HA | 0/10 (0%) | 1/10 (10%) | 8/10 (80%) |
| Arm 4: Concizumab PPX - Participants With HA | 1/52 (1.9%) | 10/52 (19.2%) | 40/52 (76.9%) |
| Arm 1: Previous OnD Treatment: No PPX - Participants With HB | 0/12 (0%) | 2/12 (16.7%) | 2/12 (16.7%) |
| Extension Phase Arm 1: Concizumab PPX - Participants With HB | 0/10 (0%) | 0/10 (0%) | 5/10 (50%) |
| Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB | 0/24 (0%) | 6/24 (25%) | 12/24 (50%) |
| Arm 4: Concizumab PPX - Participants With HB | 0/30 (0%) | 2/30 (6.7%) | 24/30 (80%) |
| Event | Arm 1: Previous On Demand (OnD) Treatment: No Prophylaxis (PPX) - Participants With HA | Extension Phase Arm 1: Concizumab PPX - Participants With HA | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HA | Arm 3: Concizumab Non-naive: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX - Participants With HA | Arm 1: Previous OnD Treatment: No PPX - Participants With HB | Extension Phase Arm 1: Concizumab PPX - Participants With HB | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB | Arm 4: Concizumab PPX - Participants With HB |
|---|---|---|---|---|---|---|---|---|---|
| Cardiac failureCardiac disorders | 0/9 | 0/7 | 0/18 | 1/10 | 0/52 | 0/12 | 0/10 | 0/24 | 0/30 |
| ArthropathyMusculoskeletal and connective tissue disorders | 0/9 | 0/7 | 0/18 | 0/10 | 0/52 | 1/12 | 0/10 | 0/24 | 0/30 |
| AscitesGastrointestinal disorders | 0/9 | 0/7 | 0/18 | 0/10 | 0/52 | 1/12 | 0/10 | 0/24 | 0/30 |
| COVID-19Infections and infestations | 0/9 | 0/7 | 0/18 | 0/10 | 1/52 | 1/12 | 0/10 | 0/24 | 0/30 |
| Hepatic failureHepatobiliary disorders | 0/9 | 0/7 | 0/18 | 0/10 | 0/52 | 1/12 | 0/10 | 0/24 | 0/30 |
| Hepatorenal syndromeHepatobiliary disorders | 0/9 | 0/7 | 0/18 | 0/10 | 0/52 | 1/12 | 0/10 | 0/24 | 0/30 |
| Liver disorderHepatobiliary disorders | 0/9 | 0/7 | 0/18 | 0/10 | 0/52 | 1/12 | 0/10 | 0/24 | 0/30 |
| Renal failureRenal and urinary disorders | 0/9 | 0/7 | 0/18 | 0/10 | 0/52 | 1/12 | 0/10 | 0/24 | 0/30 |
| Abdominal painGastrointestinal disorders | 0/9 | 0/7 | 1/18 | 0/10 | 0/52 | 0/12 | 0/10 | 0/24 | 0/30 |
| Abdominal injuryInjury, poisoning and procedural complications | 0/9 | 0/7 | 0/18 | 0/10 | 0/52 | 0/12 | 0/10 | 1/24 | 0/30 |
| Event | Arm 1: Previous On Demand (OnD) Treatment: No Prophylaxis (PPX) - Participants With HA | Extension Phase Arm 1: Concizumab PPX - Participants With HA | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HA | Arm 3: Concizumab Non-naive: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX - Participants With HA | Arm 1: Previous OnD Treatment: No PPX - Participants With HB | Extension Phase Arm 1: Concizumab PPX - Participants With HB | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB | Arm 4: Concizumab PPX - Participants With HB |
|---|---|---|---|---|---|---|---|---|---|
| COVID-19Infections and infestations | 0/9 | 0/7 | 2/18 | 3/10 | 14/52 | 0/12 | 0/10 | 3/24 | 9/30 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/9 | 0/7 | 0/18 | 2/10 | 5/52 | 0/12 | 1/10 | 3/24 | 0/30 |
| HeadacheNervous system disorders | 0/9 | 0/7 | 0/18 | 2/10 | 2/52 | 0/12 | 0/10 | 3/24 | 2/30 |
| Prothrombin fragment 1.2 increasedInvestigations | 0/9 | 0/7 | 0/18 | 2/10 | 6/52 | 0/12 | 0/10 | 0/24 | 2/30 |
| PyrexiaGeneral disorders | 0/9 | 0/7 | 0/18 | 2/10 | 3/52 | 0/12 | 0/10 | 0/24 | 2/30 |
| Fibrin D dimer increasedInvestigations | 0/9 | 0/7 | 0/18 | 1/10 | 8/52 | 0/12 | 0/10 | 1/24 | 3/30 |
| NasopharyngitisInfections and infestations | 0/9 | 0/7 | 1/18 | 1/10 | 8/52 | 0/12 | 1/10 | 2/24 | 0/30 |
| HypoaesthesiaNervous system disorders | 0/9 | 1/7 | 1/18 | 0/10 | 0/52 | 0/12 | 0/10 | 0/24 | 0/30 |
| InfluenzaInfections and infestations | 0/9 | 1/7 | 1/18 | 0/10 | 2/52 | 0/12 | 0/10 | 1/24 | 4/30 |
| RhinitisInfections and infestations | 0/9 | 1/7 | 0/18 | 0/10 | 2/52 | 0/12 | 0/10 | 0/24 | 1/30 |
Baseline characteristics were analysed based on the on-treatment without data before restart (OTexBR) analysis set. OTexBR analysis data set was defined as the observation period after the restart of treatment where participants were considered to be affected by no PPX (on-demand treatment) or concizumab PPX with the new concizumab dosing regimen.
| Age, Continuous(Years) | Arm 1: Previous On Demand (OnD) Treatment: No Prophylaxis (PPX) - Participants With HA | Arm 1: Previous OnD Treatment: No PPX - Participants With HB | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HA | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB | Arm 3: Concizumab Non-naive: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX - Participants With HB | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 34.7 ± 21.3 | 30.4 ± 17.5 | 30.7 ± 9.6 | 28.0 ± 12.0 | 43.7 ± 18.0 | 30.4 ± 13.4 | 31.6 ± 13.3 | 31.4 ± 14.2 |
| Sex: Female, Male(Participants) | Arm 1: Previous On Demand (OnD) Treatment: No Prophylaxis (PPX) - Participants With HA | Arm 1: Previous OnD Treatment: No PPX - Participants With HB | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HA | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB | Arm 3: Concizumab Non-naive: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX - Participants With HB | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Male | 9 | 12 | 18 | 24 | 9 | 46 | 30 | 148 |
| Ethnicity (NIH/OMB)(Participants) | Arm 1: Previous On Demand (OnD) Treatment: No Prophylaxis (PPX) - Participants With HA | Arm 1: Previous OnD Treatment: No PPX - Participants With HB | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HA | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB | Arm 3: Concizumab Non-naive: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX - Participants With HB | Total |
|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 0 | 1 | 2 | 4 | 3 | 12 |
| Not Hispanic or Latino | 8 | 11 | 18 | 23 | 7 | 41 | 27 | 135 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Arm 1: Previous On Demand (OnD) Treatment: No Prophylaxis (PPX) - Participants With HA | Arm 1: Previous OnD Treatment: No PPX - Participants With HB | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HA | Arm 2: Previous OnD Treatment: Concizumab PPX - Participants With HB | Arm 3: Concizumab Non-naive: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX - Participants With HA | Arm 4: Concizumab PPX - Participants With HB | Total |
|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 3 |
| Asian | 1 | 6 | 8 | 10 | 3 | 13 | 1 | 42 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 | 1 | 0 | 0 | 1 | 4 |
| White | 7 | 6 | 9 | 12 | 6 | 30 | 27 | 97 |
| More than one race | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
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Studies of the drug tested here: Concizumab