Hemophilia A Clinical Trials

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

• Male or female with diagnosis of congenital haemophilia A based on medical records.

• Ongoing participation in study NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728 at the time of transfer. Participant should qualify either of the following criteria:

∙ Participant from study NN7769-4513, who has participated in the extension part of the study for at least 12 weeks prior to enrolment in study NN7769-4532, or,

‣ Participant has completed the end of treatment visit for study NN7769-4514, NN7769-4516 or NN7769-4728.

• Participant and/or participant's parent(s)/participant's Legally acceptable representative (LAR) willingness and ability to comply with scheduled visits and study procedures, including the completion of diary.

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

• Male or female with diagnosis of congenital severe haemophilia A (endogenous FVIII activity less than (\<) 1 percentage \[%\]) with or without FVIII inhibitors based on medical records.

• Aged \<1 year at the time of signing informed consent.

• Body weight greater than or equal to (≥) 3.2 kilograms at the time of signing informed consent.

• previously untreated patients (PUPs) or minimally treated patients (MTPs) (i.e., up to 5 days of exposure to haemophilia-related treatment such as plasma-derived FVIII, recombinant FVIII, fresh frozen plasma, cryoprecipitate, or whole blood products).

• Full-term pregnancy (gestational age ≥37 weeks).

• Participant's parent(s)/LAR(s) willingness and ability to comply with scheduled visits and Arm 3 (infant) procedures, including the completion of diary and patient reported outcome (PRO) questionnaire.

• Participants \<3 months of age must show no signs of active intracranial haemorrhage at screening. This is confirmed by cranial ultrasound performed according to local practice and regardless of delivery method.

• Receipt of vitamin K prophylaxis (as per local standard practice).

⁃ Availability of historical results in medical records for:

• activated partial thromboplastin time (aPTT)

∙ FVIII levels.

⁃ Availability of historical results in medical records or pre-dose sample taken for:

• fibrinogen

∙ haematology parameters

∙ biochemistry parameters (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), bilirubin and creatinine).