Clinical Study to Investigate the PK, Efficacy, and Safety of Wilate in Patients With Severe Hemophilia A

Inclusion Criteria

• •1. Severe hemophilia A (\<1% FVIII:C) according to medical history
• •2. Male patients aged ≥12 years
• •3. Previous treatment with a FVIII concentrate for at least 150 exposure days (EDs)
• •4. Immunocompetence (CD4+ count \>200/µL)
• •5. Good documentation of the historical bleeding rate (at least for the 6 months preceding study start)
• •6. Voluntarily given, fully informed written and signed consent obtained by the patient (or parent/legal guardian in case of adolescents) before any study-related procedures are conducted
• •Whenever possible, the interval between the Screening Visit and the PK or Non-PK Visit should not exceed 30 days. If the 30-day interval is exceeded, determination of the CD4+ count is to be repeated and must be \>200/µL for patients to be enrolled (i.e., exclusion criterion no. 4).