Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novo Nordisk A/S
Age
13–70
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
