Study identification

PURI

https://redirect.ema.europa.eu/resource/36973

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 institution and networks

Institutions

Contact details

Sinem Ezgi Gulmez

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:
Actual:

Date of interim report, if expected

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Non for-profit organisation (e.g. charity)

More details on funding

Institute de Recherche en Santé Publique (IReSP)
Study protocol
Initial protocol

EPIHAM_Study Protocol_V2.0_20150715

English (1.02 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable