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

Inclusion Criteria:

• Male patients ≥ 12 years, with signed informed consent by the patient, or thepatient'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 ahistory 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 intravenousimmunoglobulin (IVIG)
• Planned elective surgery
• Current enrolment or willing to enroll in any other experimental study during the timeof current trial
• Subjects assessed by the investigator to be unable or unwilling to comply with therequirements of the protocol (e.g.: physical, psychological and mental problems)