EUREKIX

• Research type

  Research Study

• Full title

  EUropean REgistry in Children below six years of age treated with BeneFIX (EUREKIX).

• IRAS ID

  122447

• Contact name

  Ri Liesner

• Contact email

  ri.liesner@gosh.nhs.uk

• Sponsor organisation

  Pfizer

• Clinicaltrials.gov Identifier

  ENCEPP/SDPP/3788, EU Post Authorisation Study (PAS)register

• Research summary

  The objective of the study is to collect data in Europe regarding safety (primary endpoint) and efficacy (secondary endpoint) of treatment with rFIX (BeneFIX®) in children below 6 years of age treated in the routine clinical setting. This is a two phase, non interventional trial which includes a retrospective and/or prospective data collection period.
  The retrospective data collection period will involve data collection from the participants medical records.
  The prospective data collection period will involve data collection from medical records/patient treatment diaries. The treating Physician/Investigator may also ask the participant questions relating to bleeding events or other events (which may constitute as Adverse Events) during the observation period. These questions are asked by treating physicians to Haemophilia patients as standard practise. These questions are therefore not to be considered interventional. Because the study is collecting standard information only, there is no change to the patient's standard of care.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  14/LO/1540

• Date of REC Opinion

  23 Sep 2014

• REC opinion

  Favourable Opinion