A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without Inhibitors

Inclusion Criteria:

• Informed consent/assent obtained before any study-related activities. Study-relatedactivities are any procedures that are carried out as part of the study, includingactivities to determine suitability for the study.

• Diagnosis of congenital severe haemophilia A (FVIII below 1%) or moderate/severecongenital haemophilia B (FIX (coagulation factor IX) below or equal to 2%), orcongenital haemophilia with inhibitors.

• For arm 1 only: Male aged below 12 years of age at the time of signing informedconsent.

• For arm 1 only: Patients with inhibitors (haemophilia A with inhibitors orhaemophilia B with inhibitors)

1. Patients with HAwI (haemophilia A with inhibitors) with historical medicalrecords of a total of at least 26 weeks of on-demand treatment (On-demand orPPX treatment qualifying for this study is understood as patient-treatmentsolely for bleeds with intravenous coagulation factor-containing products)within the last 52 weeks prior to enrolment (For patients below 1 year of agethat have been diagnosed with haemophilia <1 year prior to enrolment,historical medical records from time of diagnosis will suffice as long asmedical records of a total of at least 26 weeks of relevant treatment isavailable).

2. Patients with HBwI (haemophilia B with inhibitors) with historical medicalrecords of a total of at least 26 weeks of on-demand treatment (On-demand orPPX treatment qualifying for this study is understood as patient-treatmentsolely for bleeds with intravenous coagulation factor-containing products)within the last 52 weeks prior to enrolment (For patients below 1 year of agethat have been diagnosed with haemophilia <1 year prior to enrolment,historical medical records from time of diagnosis will suffice as long asmedical records of a total of at least 26 weeks of relevant treatment isavailable).

3. Patients with HBwI regardless of the regimen and duration of previoushaemophilia treatment (On-demand or PPX treatment qualifying for this study isunderstood as patient-treatment solely for bleeds with intravenous coagulationfactor-containing products)

• For arm 1 only: Patients without inhibitors (haemophilia A or haemophilia B)

1. Patients with historical medical records of at least 52 weeks of on-demandtreatment (On-demand or PPX treatment qualifying for this study is understoodas patient-treatment solely for bleeds with intravenous coagulationfactor-containing products; Surgery related PPX or short-term PPX (e.g., inrelation to a severe bleed) is not allowed) during the last year prior toenrolment and with at least 3 documented treated bleeds (For participants lessthan (<) 2 years of age there is no limitation for number of documented treatedbleeds in the medical history) during this period

2. Patients with historical medical records of a total of at least 26 weeks of PPX (prophylaxis) treatment (On-demand or PPX treatment qualifying for this studyis understood as patient-treatment solely for bleeds with intravenouscoagulation factor-containing products) within the last 52 weeks prior toenrolment (For patients below 1 year of age that have been diagnosed withhaemophilia <1 year prior to enrolment, historical medical records from time ofdiagnosis will suffice as long as medical records of a total of at least 26weeks of relevant treatment is available)

• For arm 2 only: Male patients (regardless of age) previously treated with concizumabvia compassionate use.

Exclusion Criteria:

• Known or suspected hypersensitivity to study intervention or related products.

• Known inherited or acquired coagulation disorder other than congenital haemophilia.

• Ongoing or planned Immune Tolerance Induction treatment.

• History of thromboembolic disease (aIncludes arterial and venous thrombosisincluding myocardial infarction, pulmonary embolism, cerebral infarction/thrombosis,deep vein thrombosis, other clinically significant thromboembolic events andperipheral artery occlusion.). Current clinical signs of or treatment forthromboembolic disease. Patients who in the judgement of the investigator areconsidered at high risk of thromboembolic events (Thromboembolic risk factors couldinclude, but are not limited to, hypercholesterolemia, diabetes mellitus,hypertension, obesity, smoking, family history of thromboembolic events,arteriosclerosis, other conditions associated with increased risk of thromboembolicevents).