Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A

Clinical Study to Investigate the Efficacy, Safety, and Immunogenicity of Human-cl rhFVIII in Previously Treated Patients With Severe Hemophilia A

This study will determine the efficacy of human-cl rhFVIII in previously treated patients with severe hemophilia A during prophylactic treatment, treatment of bleeding episodes and in surgical prophylaxis.

Inclusion Criteria:

• Severe hemophilia A ((FVIII:C <= 1%)
• Male subjects >= 12 years of age
• Previously treated with FVIII concentrate, at least 50 EDs
• Immunocompetent (CD4+ count > 200/ul)
• Negative for anti- HIV; if positive, viral load < 200 particles/u; or <400,000 copies/mL

Exclusion Criteria:

• Other coagulation disorder than hemophilia A
• Present of past FVIII inhibitor activity (.= 0.6 BU)
• Severe liver and kidney disease
• Receiving of scheduled to receive immuno-modulating drugs