Research study to look at how well the drug Concizumab works in your body if you have haemophilia without inhibitors

Prior treatment

• Treatment with emicizumab within 180 days before screening
• Presence of confirmed inhibitor ≥0.6 BU at screening
• Previous participation in this trial. Participation is defined as signed informed consent. However, this is not applicable for patients who were screen failed at Sponsor’s decision due to the treatment pause
• Participation in any clinical trial of an approved or non-approved investigational medicinal product within 5 half-lives or 30 days from screening, whichever is longer (not applicable for NN7415-4255 patients enrolled prior to the treatment pause).

Other illness

• Known or suspected hypersensitivity to any constituent of the trial product or related products
• A known systemic inflammatory condition requiring systemic treatment at screening
• Known history of inhibitors ≥0.6 BU in the last 5 years according to the medical records.
• Any disorder, except for conditions associated with haemophilia, which in the investigator’s opinion might jeopardise patient’s safety or compliance with the protocol
• Known inherited or acquired coagulation disorder other than congenital haemophilia
• History of thromboembolic disease. Current clinical signs of, or treatment for thromboembolic disease. Patients who in the judgement of the investigator are considered at high risk of thromboembolic events

Lab values

• Platelets ≤100x109/L at screening
• Fibrinogen below laboratory lower normal limit at screening
• Hepatic dysfunction defined as AST and/or ALT >3 times the upper limit combined with total bilirubin > 1,5 times the upper limit at screening
• Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) ≤30 ml/min/1.73 m2 for serum creatinine measured at screening

• 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 suitability for the trial
• Male aged ≥12 years at the time of signing informed consent
• Body weight >25 kg at screening
• Congenital severe haemophilia A (FVIII < 1%) or moderate/severe B (FIX ≤ 2%).
• Documented treatment with coagulation factor containing product in the last 24 weeks (not applicable for NN7415-4255 (explorer5) patients enrolled prior to the treatment pause).