rFVIII-Fc (Produced by AryoGen Pharmed Co.) Pharmacokinetic Study

Inclusion Criteria: * Male patients ≥ 12 years, with signed informed consent by the patient, or the patient's legally authorized representative for patients under the legal age * Diagnosed with severe hemophilia A (endogenous FVIII \<1% \[1 IU/dL\]) * History of at least 150 documented prior exposure days to any FVIII product * Having adequate bone marrow and organ function: * Plt ≥ 80,000 cells/µL * Hb ≥ 8 mg/dL * eGFR ≥ 30 mL/min * ALT or AST ≤ 5×ULN * Serum bilirubin ≤ 1.5×ULN Exclusion Criteria: * Measurable anti-drug antibody activity against FVIII (≥ 0.6 BU/mL) at screening or a history of developing anti FVIII antibody * History of other coagulation disorders except for hemophilia A * Acute hemorrhagic state * Infection with HCV or HBV * HIV-positive patients * Infusion of any products containing FVIII within 7 days prior to first administration * Previous treatment with commercially available extended half-life FVIII products * Receiving drugs which increase bleeding tendency (e.g: Anti-coagulants, antiplatelets, omega 3, Vit E, etc.) within 2 weeks of screening. NSAIDs are permitted. * Current systemic treatment with immunosuppressive drugs * Hypersensitivity or anaphylaxis associated with any FVIII concentrate or intravenous immunoglobulin (IVIG) * Planned elective surgery * Current enrolment or willing to enroll in any other experimental study during the time of current trial * Subjects assessed by the investigator to be unable or unwilling to comply …