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
Scheduled dose visit in a non-bleeding state. Single dose of NNC 0078-0000-0007 (vatreptocog alfa (activated)) every 3 months.
Age
12–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Male patient with clinical diagnosis of congenital haemophilia A or B and inhibitors to coagulation factors VIII or IX
Minimum of five bleeds requiring haemostatic drug treatment within the previous 12 months at trial entry
You may not be if
Previous participation in this trial defined as withdrawal after administration of trial product
Patient has received an investigational medicinal product within 30 days prior to this trial
Congenital or acquired coagulation disorders other than haemophilia A or B
Any clinical signs or known history of arterial thrombotic events or of deep venous thrombosis or pulmonary embolism (as defined by available medical records)
Platelet count of less than 50,000 platelets/mcL (at the screening visit)
ALAT (alanine-transaminase) of more than 3 times the upper normal limit (according to laboratory reference ranges)
Factor VIII/IX Immune Tolerance Induction regimen planned to occur during the trial
Ongoing bleeding prophylaxis regimens or planned bleeding prophylaxis to occur during the trial
HIV (Human Immunodeficiency Virus) positive with current CD4+ count of less than 200/mcL (defined by medical records)
