Prevalence of Acute Liver Injury

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/104335
• EU PAS number:
  EUPAS104334
• Study ID:
  104335
• Official title and acronym:
  Prevalence of Acute Liver Injury
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Romania

  Spain
• Study description:
  A descriptive study of the yearly prevalence of acute liver injury, overall and stratified by gender and age group, in five EU countries
• Study status:
  Finalised

Research institution and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 11/04/2022

Actual: 11/04/2022

Study start date

Planned: 11/04/2022

Actual: 11/04/2022

Date of final study report

Planned: 03/06/2022

Actual: 02/06/2022

Sources of funding

EMA

Study protocol

Initial protocol

Analysis-Plan-Simple study- 202112_v2.0_For Publication_CLEAN

Regulatory

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