Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Octapharma
Age
Any age
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Haemophilia A (FVIII:C ≤ 2%) based on medical history; at least 100 patients should have severe haemophilia A (FVIII:C \< 1%)
Male patients of any age
Previous treatment with a FVIII concentrate for more than 150 EDs
Availability of detailed documentation (patient diary, log book, etc.) covering either the last 50 EDs or the last 2 years per patient to confirm treatment modality (i.e., prophylaxis, on-demand, recent surgery, or immune tolerance induction)
Inhibitor negative (\< 0.6 BU) at study entry as confirmed by a recovery test with previous FVIII product and inhibitor test in a central laboratory
Immunocompetence (CD4+ count \> 200/µL), HIV-negative, or having a viral load \< 200 particles/µL or \< 400,000 copies/mL
Decision to prescribe Human-cl rhFVIII before enrolment into the study
Written informed consent by the patient or the patient's parent or legal guardian
Clareo Health | Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ