Investigating Safety and Pharmacokinetics of 2 Different Single Doses of NNC128-0000-2011 in Haemophilia A or B Patients

Inclusion criteria

• Patients diagnosed with haemophilia A or B (with or without inhibitors and irrespective of severity) based on medical records
• Japan: A legally acceptable representative (LAR) is required for patients between 18 and 19 years
• Body weight less than or equal to 100.0 kg
• Body Mass Index (BMI) less than or equal to 30.0 kg/m^2

Exclusion criteria

• Known or suspected allergy to trial product(s) or related products (including rFVIIa)
• Previous participation in this trial defined as administration of trial product
• The receipt of any investigational product within 30 days prior to trial start (screening)
• Congenital or acquired coagulation disorders other than haemophilia A or B
• Receipt of Immune Tolerance Induction (ITI) within the last 30 days prior to screening
• Any surgery within 30 days prior to screening
• Planned surgery within the trial period
• Platelet count below 50,000 platelets/mcL (based on medical records within the last 1 month or laboratory results at screening)
• Prothrombin time (PT) above 4 times Upper limit of normal (ULN) or International normalised ratio (INR) greater than 1.7
• Hepatic dysfunction or severe hepatic disease as evaluated by the investigator (trial physician)
• Renal dysfunction (dialysis) and/or creatinine levels more than or equal to 20% above upper normal limit (according to medical records or laboratory results at screening)
• Advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.)
• Any disease, condition, or medication which, according to the investigator's (trial physician) judgement, could imply a potential hazard to the patient or interfere with the trial participation or trial outcome
• Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation