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)