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

Update Il y a 5 ans
Reference: EUCTR2011-003075-11

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

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Extract

The primary objective of the study is to evaluate the long-term safety of rFIXFc in subjects with hemophilia B.


Inclusion criteria

  • The medical condition to be investigated is Hemophilia B, or Christmas disease. Hemophilia B is a deficiency in the clotting FIX and is a recessively inherited coagulation disorder due to an X-chromosome mutation carried by females and expressed mainly by males, affecting approximately 80,000 people worldwide