Factor X in the prophylaxis of bleeding in Children <12yrs

• Research type

  Research Study

• Full title

  Ten 02 - A Phase III Open Label Multicentre Study to Confirm 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 of 12 Years

• IRAS ID

  118198

• Contact name

  Sarah Jenkins

• Contact email

  sarah.jenkins@bpl.co.uk

• Sponsor organisation

  Bio Products Laboratory Ltd

• Eudract number

  2012-003093-98

• Clinicaltrials.gov Identifier

  NCT01721681

• Duration of Study in the UK

  1 years, 2 months, 16 days

• Research summary

  Factor X is being developed as a treatment for participants with a deficiency in clotting Factor X.

  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 6 months (26 weeks) in children <12 years old.

  The secondary objectives of the study is to

  1) Assess the pharmacokinetics of FACTOR X after a signle dose of 50 IU/kg
  2) Assess the safety of FACTOR X when given as routine prophylaxis over 6 months

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  15/LO/0014

• Date of REC Opinion

  24 Feb 2015

• REC opinion

  Further Information Favourable Opinion