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
0–12
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Male patients with moderately severe or severe congenital haemophilia B with a Factor IX activity level below or equal to 2% according to medical records
Age below or equal to 12 years (until patient turns 13 years, at time of inclusion)
Body weight above or equal to 10 kg
History of at least 50 exposure days (EDs) to other FIX products
The patient and/or parent(s)/caregiver are capable of assessing a bleeding episode, keeping an electronic diary (eDiary), capable of conducting home treatment and otherwise able to follow trial procedures
You may not be if
Known history of FIX inhibitors
Current FIX inhibitors above or equal to 0.6 Bethesda Units (BU)
Congenital or acquired coagulation disorder other than haemophilia B
Platelet count below 50,000/mcL at screening
Alanine aminotransferase (ALT) above 3 times the upper limit of normal reference ranges at screening
Creatinine level above or equal to 1.5 times above the upper normal limit of normal reference ranges at screening
Human immunodeficiency virus (HIV) positive, defined by medical records, and with a CD4+ lymphocyte count below or equal to 200/mcL
Immune modulating or chemotherapeutic medication (except single pulse treatment, inhaled and topical steroids)
Previous arterial thrombotic events (myocardial infarction and intracranial thrombosis, as defined by medical records)
Clareo Health | Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.
