A PK study of BPLs FX in patients with FX deficiency

• Research type

  Research Study

• Full title

  A Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL’s High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency

• IRAS ID

  23836

• Sponsor organisation

  Bio Products Laboratory

• Eudract number

  2009-011145-18

• ISRCTN Number

  N/A

• Research summary

  Factor X is being developed as a treatment for participants with a deficiency in clotting Factor X. The purpose of the study is to look at how Factor X behaves in the body, to determine this Pharmacokinetic (PK) assessments will be taken from participants to see how much Factor X is in a participants blood and how long the Factor X stays there. The study will also look at how well Factor X works at treating bleeds by seeing how severe those bleeds are and how long each bleed lasts. Finally the study will look at how safe Factor X is by closely following the participants?? progress during the study.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  09/H1306/82

• Date of REC Opinion

  2 Nov 2009

• REC opinion

  Further Information Favourable Opinion