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
12–65
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Male subjects with the diagnosis of severe (FVIII less than or equal to 1%) haemophilia A from age 12 (except for Israel where the age limit will be 18 for the first 10 subjects recruited in the trial) to 56 years having a weight of 10 to 120 kg
Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)
No history of FVIII inhibitors greater than or equal to 0.6 BU/mL. The inhibitor should be measured regularly for at least the last 8 years or since the first treatment of haemophilia A
No detectable inhibitors to FVIII (greater than or equal to 0.6 BU/mL) (as assessed by a Central Laboratory at the time of screening)
You may not be if
Congenital or acquired coagulation disorders other than haemophilia A
Creatinine levels 50% above normal level (as defined by central laboratory range)
Known or suspected allergy to trial product (N8) or related products
Clareo Health | Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects
