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Immunogenicity [ Time Frame: maximum 5 years (100 exposure days) ]
Number of patients that develop an inhibitor
Secondary Outcome Measures
Efficacy [ Time Frame: Maximum 5 years (100 exposure days) ]
Efficacy of human cl rhFVIII during prophylactic treatment (frequency of break thorugh blleds) Efficacy of human cl rhFVIII during treatment of bleeds (Number of injections needed to stop a bleed) Efficacy of human cl rhFVIII during surgical prophylaxis (compare expected estimated blood loss versus actual estimated blood loss)
Other Outcome Measures:
Safety and tolerability [ Time Frame: 5 years ]
Measure vital signs, Adverse events, and standard hematology and chemistry laboratory parameters. This assessment is descriptive)
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Ages Eligible for Study:
Child, Adult, Senior
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Severe Hemophilia A (FVIII:C <1%)
No previous treatment with with FVIII concentrates or other blood prodcuts containing FVIII
Diagnosis with a coagulation disorder other than Hemophilia A
Severe liver or kidney disease
Concomitant treatment with any systemic immunosuppressive drug