Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A

Prospective, Open-label, Multi-centre Phase 3b Study to Assess the Efficacy and Safety of Personalized Prophylaxis With Human-cl rhFVIII in Previously Treated Adult Patients With Severe Haemophilia A

The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between doses. Because trough FVIII levels are likely to be important predictors of the efficacy of prophylaxis, the focus of this study is on pharmacokinetic (PK) data.

Inclusion Criteria:

• Severe Haemophilia A (FVIII:C < 1%)
• Male patients >= 18 years of age
• Previous treatment with a FVIII concentrate for at least 150 EDs
• Good documentation regarding dosing and bleeding frequency in the 6 months preceding study start
• Immunocompetence (CD4+ count > 200/uL)

Exclusion Criteria:

• Any coagulation disorder other than Haemophilia A
• Present of past FVIII inhibitor activity
• Severe liver or kidney disease