A Phase 2/3, Multi-Center, Open Label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (BAX 855) Administered for Prophylaxis and Treatment of Bleeding in Previously Treated Patients With Severe Hemophilia A
A Phase 2/3, Multi-Center, Open Label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (BAX 855) Administered for Prophylaxis and Treatment of Bleeding in Previously Treated Patients With Severe Hemophilia A
To assess efficacy and safety, including immunogenicity of BAX 855 administered as prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated patients (PTPs) with severe hemophilia A To determine the pharmacokinetic (PK) parameters of BAX 855.
Main Inclusion Criteria:
Main Exclusion Criteria:
Kitakyushu-shi, Fukuoka 807-8556, Japan
Nishinomiya-shi, Hyōgo 663-8501, Japan
Kawasaki-shi, Kanagawa 216-8511, Japan
Shinjuku-ku, Tokyo-To 160-0023, Japan
Suginami-ku, Tokyo-To 167-8515, Japan
Vilnius, LT-08406, Lithuania
Donetsk, 83045, Ukraine