Clinical Trial: A Study to Investigate BPL's Factor X in the Prophylaxis of Bleeding in Children <12 Years

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional



Official Title: A Phase III Open, Multicentre Study to Investigate the Safety, Pharmacokinetics and Efficacy of BPL's High Purity Factor X in the Prophylaxis of Bleeding in Factor X Deficient Children Under the Age o

Brief Summary:

The primary objective of the study is to assess the efficacy of FACTOR X in the prevention of bleeding when given as routine prophylaxis over 12 months.

The secondary objectives of the study are:

  1. To assess the pharmacokinetics of FACTOR X after a single dose of 50 IU/kg.
  2. To assess the safety of FACTOR X when given as routine prophylaxis over 6 months (26 weeks).