Prevalence of hypereosinophilic syndrome (HES) in the paediatric population in EU (Hypereosinophilic syndrome in children)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45203
• EU PAS number:
  EUPAS45202
• Study ID:
  45203
• Official title and acronym:
  Prevalence of hypereosinophilic syndrome (HES) in the paediatric population in EU (Hypereosinophilic syndrome in children)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany
• Study description:
  HES is a constitutes a rare and heterogeneous group of disorders, defined as persistent and marked blood eosinophilia and/or tissue eosinophilia associated with a wide range of clinical manifestations reflecting eosinophil-induced tissue/organ damage 1. There is only limited information in the literature regarding the prevalence of this conditions in children and clarification of this would help inform the feasibility of current and future clinical trials. This study aims to calculate the yearly prevalence of hypereosinophilic syndrome in children 0-5 and 6-11 years of age in two European countries, France and Germany.
• Study status:
  Finalised

Research institution and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 29/11/2021

Actual: 29/11/2021

Study start date

Planned: 01/12/2021

Actual: 01/12/2021

Data analysis start date

Planned: 05/12/2021

Actual: 05/12/2021

Date of final study report

Planned: 10/12/2021

Actual: 10/12/2021

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable