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

Study identification

• EU PAS number:
  EUPAS3788
• Study ID:
  25611
• Official title and acronym:
  EUropean REgistry in Children below six years of age treated with BeneFIX (EUREKIX)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Denmark

  Finland

  France

  Italy

  Netherlands

  Spain

  Sweden

  United Kingdom
• Study description:
  This is a two phase, non-interventional, multicenter trial including a retrospective (Phase I) and/or prospective (Phase II) data collection period. Retrospective data will be collected only if patients have been treated with BeneFIX for at least 12 months ahead of the inclusion in the study. In order to ensure consistent data quality, retrospective documentations must not cover a time period longer than 8 years ago i.e. if a patient is 8 years of age, his treatment with BeneFIX between 0-6 years of age may still be retrospectively documented.Prospective data will be collected if patients will be able to follow 12 to 24 months of treatment with BeneFIX before they reach 6 years of age.
• Study status:
  Finalised

Research institutions and networks

Institutions

Great Ormond Street Hospital for Children NHS Foundation Trust

Multiple centres: 40 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:30/11/2011

Actual:30/11/2011

Study start date

Planned:15/12/2012

Actual:12/07/2013

Data analysis start date

Planned:31/08/2016

Actual:16/03/2017

Date of final study report

Planned:31/03/2017

Actual:28/03/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable