EPIHAM: Drug-induced liver injury leading to hospital admission: a study in national healthcare insurance databases

Study identification

• EU PAS number:
  EUPAS7549
• Study ID:
  36973
• Official title and acronym:
  EPIHAM: Drug-induced liver injury leading to hospital admission: a study in national healthcare insurance databases
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  EPIHAM is to identify in the national healthcare databases all hospital admissions for toxic or unexplained liver injuries. It will be done within the French national health care systems databases, which include all reimbursed health-care expenses, and all hospital admissions with ICD-10 coded admission diagnoses. The overall methodological approach will be initially that of a case-population study to compare event rates with those found in SALT. This will be completed by other methods: a case-crossover approach, a classical case-control study, and a propensity-score adjusted or matched cohort study of products selected from the case-population data.The routines created for this project may be reused to set up regular surveillance of drug-related hepatic disorders in the French population
• Study status:
  Finalised

Research institutions and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

Study timelines

Date when funding contract was signed

Actual:17/07/2014

Study start date

Planned:02/05/2016

Actual:16/10/2014

Data analysis start date

Planned:01/09/2016

Actual:16/10/2014

Date of interim report, if expected

Actual:17/07/2015

Date of final study report

Planned:31/12/2016

Actual:31/01/2017

Sources of funding

Non-for-profit organisation (e.g. charity)

More details on funding

Institute de Recherche en Santé Publique (IReSP)

Regulatory

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