Efficacy and Safety of Recombinant Factor VIII (GreenGene) in Patients With Hemophilia A

Inclusion Criteria: * Hemophilia A patients at least 12 years of age * At least 150 treatment exposure-days to previous FVIII products * FVIII≤2% at screening or diagnosis (FVIII≤1% for PK study) * CD4 Lympocyte cell count\>400/㎕ * Patients willing to cooperate for the study * Patient's or legal guardian's consent to participate in the study Exclusion Criteria: * FVIII inhibitor(neutralizing antibody to FVIII)≥0.6 Bethesda Units * Coagulation disorders other than hemophilia A (e.g. Idiopathic Thrombocytopenic Purpura, von Willebrand Disease) * Platelet count≤100,000㎣ * Subjects with clinical evidence of symptomatic HIV disease regardless of HIV-seroposive/seronegative * Subjects with rFVIII antibody, mouse IgG antibody, or CHO antibody * Creatinine levels more than 2 times of reference rage, GOT and GPT levels more than 3 times of reference range, diabetes mellitus or other metabolic disorder * Subjects with diastolic blood pressure≥100mmHg not controlled with antihypertensive medications * Anemia(hemoglobin\<12g/dL) * Subjects with severe or life-threatening bleeding just before entry into the trial * Subjects with a history of treatment failure due to formation of inhibitor to FVIII * Subjects with a history of severe hypersensitive reactions to FVIII concentrate * Subjects requiring pre-medication for FVIII infusion(e.g. antihistamines, etc)