Mobile

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...

Mise à jour : Il y a 5 ans
Référence : EUCTR2009-014295-21

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

  • | Pays :
    • -
  • | Organes :
    • -
  • | Spécialités :
    • -

Extrait

The primary objectives of the study are: • To evaluate the safety and tolerability of rFIXFc • To evaluate the efficacy of rFIXFc in all treatment arms: • To evaluate the effectiveness of prophylaxis over on-demand therapy by comparing the annualized number of bleeding episodes between subjects receiving rFIXFc on each prevention regimen (Arm 1 and Arm 2) and subjects receiving rFIXFc on an on-demand regimen (Arm 3)

Critère d'inclusion

  • 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

Liens