Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B

Inclusion Criteria:

- 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 at the time of signing informed consent

- Patients with the diagnosis of haemophilia B (FIX (coagulation factor IX) activity
level below or equal to 2%) based on medical records or central laboratory results

- Previously untreated or exposed to FIX containing products less than or equal to 3
exposure days (5 previous exposures to blood components is acceptable)

Exclusion Criteria:

- Any history of FIX inhibitors (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 B

- 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)/LAR(s) (legally acceptable representative) mental incapacity,
unwillingness to cooperate, or a language barrier precluding adequate understanding
and cooperation