To evaluate Safety and efficacy and pharmacokinetics, FVIII Inhibitor titers of Hemlibra subcutaneous injection (SC inj.) in Korean Hemophilia A patients with/without FVIII Inhibitors.
Target subject : 1. Patients with Hemophilia A with FVIII inhibitors 2. Patients with severe Hemophilia A without FVIII inhibitors.
Study Type
OBSERVATIONAL
Enrollment
17
Safety and efficacy and PK, FVIII inhibitor titers will be evaluated by follow-up observation.
Yonsei University Severance Hospital
Seoul, South Korea
RECRUITINGAdverse events
AEs will be described for AEs and Adverse Drug Reactions (ADRs), Adverse Events of Special Interest (AESIs), other important AEs. Severity, outcome, causal relationship with study drug, etc. of AEs will be analyzed.
Time frame: for 24weeks
Annualized Bleeding episode Rate (ABR)
The number of bleeds will be also annualized for each patient using the following formula
Time frame: for 24weeks
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