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

A Randomized, Two-armed, Double-blind, Single-dose, Crossover, Two-sequence, Bioequivalence Clinical Trial to Compare PK Parameters and Safety of rFVIII-Fc (AryoGen Pharmed Co.) Versus Elocta® in PTPs With Severe Hemophilia A

The study is designed as a randomized, two-armed, double-blind, single-dose, crossover, two-sequence, active-controlled, multi-center, bioequivalence clinical trial with a primary endpoint of dose-normalized area under the curve (dnAUC last)

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 with the requirements of the protocol (e.g.: physical, psychological and mental problems)