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
0–6
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Age below 6 years
Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the patient)
Male patients diagnosed with congenital severe haemophilia A (FVIII level equal to or below 1%)
No prior use of purified clotting factor products (previous exposure, equal to or less than 5 ED to blood components, e.g. cryoprecipitate, fresh frozen plasma, is accepted) including commercially available NovoEight® /Novoeight®
You may not be if
Known or suspected allergy to hamster protein or intolerance to trial product(s) or related products
Previous participation in this trial defined as withdrawal after administration of trial product
Congenital or acquired coagulation disorders other than haemophilia A
Any history of Factor VIII inhibitor
Ongoing treatment or planned treatment during the trial with immunomodulatory agents (e.g. intravenous immunoglobulin (IVIG), routine systemic corticosteroids)
Clareo Health | Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A
