Lead Sponsor

Novo Nordisk A/S

Age

0 - 6 years

Sex

MALE

Healthy Volunteers

No

•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, age below 6 years of age at the time of signing informed consent
•Diagnosis of severe haemophilia A (FVIII activity level 1%) based on medical records or central laboratory results
•No prior use of purified clotting factor products (5 previous exposures to blood components is acceptable)

•Any history of FVIII inhibitor (defined by medical records) - Known or suspected hypersensitivity to trial product or related products
•Previous participation in this trial. Participation is defined as first dose administered of trial product
•Receipt of any investigational medicinal product within 30 days before screening
•Congenital or acquired coagulation disorder other than haemophilia A
•Any chronic disorder or severe disease which, in the opinion of the Investigator, might jeopardise the patient's safety or compliance with the protocol
•Patient's parent(s')/legally acceptable representative (LAR(s')) mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation

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