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–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
12 years of age or older (at least 18 years in Croatia, France and United Kingdom (UK))
Clinical diagnosis of congenital haemophilia A or B with a current positive inhibitor titre and a known peak inhibitor of above 5 Bethesda units (BU) (present or in the past) to human FVIII or IX and known antihuman FVIII or IX anamnestic response
Minimum of 2 joint bleeds (haemarthroses of ankles, knees, or elbows) requiring haemostatic drug treatment within the previous 6 months, or at least 4 joint bleeds (hemarthroses of ankles, knees, or elbows) requiring haemostatic drug treatment within the previous 12 months at trial entry
You may not be if
Known allergy to rFVIIa, and/or suspected allergy to trial product
Platelet count lower than 50,000 mm\^3 based on medical records at trial entry (visit 1)
Any clinical signs or history of thromboembolic events
Advanced atherosclerotic disease
Severe liver disease based on medical records within the past 12 months at trial entry (Visit 1), as defined by alanine aminotransferase (ALAT) above 3 times the upper limit of normal reference range
Known active pseudo tumours (documented bleeding requiring treatment within the last 3 months
Subject had any (major) surgical procedure in the 30 days prior to screening into the trial. a. Catheter, ports and dental extractions do not count as surgeries and will not exclude the subject
Clareo Health | Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds
