Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B

An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Patients With Haemophilia B

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.

Inclusion Criteria:

• Patients with haemophilia B with a FIX activity below or equal to 2%
• Male patients with moderately severe or severe congenital haemophilia B with a FIX activity below or equal to 2% according to medical records
• History of at least 150 exposure days to other FIX products
• Scheduled major surgery

Exclusion Criteria:

• Known history of FIX (coagulation factor nine) inhibitors based on existing medical records, laboratory report reviews and patient and LAR (legal acceptable representative) interviews
• Current FIX (coagulation factor nine) inhibitors above or equal to 0.6 Bethesda Units (central laboratory)
• Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records)
• ALT (alanine aminotransferase) 3 times the upper limit of normal reference ranges at screening (central laboratory)
• Immune modulating or chemotherapeutic medication