Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A

Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of Human-cl rhFVIII, a Newly Developed Human Cell-line Derived Recombinant FVIII Concentrate in Previously Treated Patients With Severe Hemophilia A

This is a clinical study to investigate the pharmacokinetics, efficacy, safety and immunogenicity of human-cl rhFVIII, a newly developed human cell-line derived recombinant FVIII concentrate in previously treated patients with severe Hemophilia A.

Inclusion Criteria:

• Severe hemophilia A (FVIII:C <= 1%)
• Male subjects between 12 and 65 years of age
• Body weight 25 kg to 110 kg
• Previously treated with FVIII concentrate for at least 150 EDs

Exclusion Criteria:

• Other coagulation disorder than hemophilia A
• Present or past FVIII inhibitor activity