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A clinical study involving people with severe haemophilia A to look at how safe an experimental replacement factor VIII protein (known as rFVIIIFc) is to take and how well it works to prevent and stop...

Update Il y a 5 ans
Reference: EUCTR2010-020558-33

A clinical study involving people with severe haemophilia A to look at how safe an experimental replacement factor VIII protein (known as rFVIIIFc) is to take and how well it works to prevent and stop bleeds

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Extract

• To evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis, weekly, on-demand, and surgical treatment regimen • To evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm 1) • To evaluate the efficacy of rFVIIIFc administered as an on demand (Arm 3) and surgical treatment regimen

Inclusion criteria

  • Severe hemophilia A - defined as <1 IU/dL (<1%) endogenous FVIII

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