Status: Finalised First registered on: 29/09/2014
Last updated on: 31/08/2020
1. Study identification
EU PAS Register NumberEUPAS7549
Official titleEpidemiology of acute hepatotoxicity from medicines
Study title acronymEPIHAM
Study typeObservational study
Brief description of the studyEPIHAM 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
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Professor
Last name Gulmez
First name Sinem Ezgi
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed17/07/2014
Start date of data collection02/05/201616/10/2014
Start date of data analysis01/09/201616/10/2014
Date of interim report, if expected17/07/2015
Date of final study report31/12/201631/01/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
CharitiesInstitute de Recherche en Santé Publique (IReSP)100
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Gulmez
First name Sinem Ezgi
Address line 1Service de Pharmacologie médicale CIC Bordeaux CIC1401 Université de Bordeaux Bâtiment Le Tondu - Case 41 146, Rue Léo Saignat
Address line 2Bat Tondu, Case 41 
Address line 3146, rue Leo Saignat 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557579564 
Alternative phone number 
Fax number (incl. country code)33557574740 
Email address cecile.droz@u-bordeaux.fr
Public Enquiries
Title Professor 
Last name Gulmez 
First name Sinem Ezgi 
Address line 1Service de Pharmacologie médicale CIC Bordeaux CIC1401 Université de Bordeaux Bâtiment Le Tondu - Case 41 146, Rue Léo Saignat 
Address line 2Bat Tondu, Case 41 
Address line 3146, rue Leo Saignat 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557579564 
Alternative phone number 
Fax number (incl. country code)33557574740 
Email address cecile.droz@u-bordeaux.fr 
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