Status: Finalised First registered on: 13/06/2014
Last updated on: 03/05/2021
1. Study identification
EU PAS Register NumberEUPAS5555
Official titleStudy of Acute Liver Transplant-II
Study title acronymSALT-II
Study typeObservational study
Brief description of the studyThe SALT-I study created a network of 55 liver transplant centres in seven European countries. It also accumulated a considerable body of data on drug-exposed acute liver failure in Europe. The national coordinators of these centres have expressed a desire to continue this collaboration and monitor severe acute hepatitis in Europe. Furthermore, the main objective of SALT-I concerned only the risks associated with NSAIDs. One of the main objectives of the SALT-II study is to assess the risks associated with other drugs than NSAID. The incidence of these very severe drug-induced acute liver failure is very low: we could identify only 40 cases associated with NSAIDs over 2005-2007, and fewer still with other drugs except paracetamol. To improve the precision of the measures of incidence, and to be able to identify emergent risks, it would seem desirable to increase the number of cases identified, by continuing the study for the next six years (2008-2013), and studying the possibility of expanding the network to other countries (Germany, Spain, Nordic or Eastern European countries).
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
Multiple centres

In total how many centres are involved in this Study?21

Bordeaux PharmacoEpi
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 signed20/12/2013
Start date of data collection01/07/201401/07/2014
Start date of data analysis12/02/2016
Date of interim report, if expected27/11/2015
Date of final study report30/12/201613/07/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
CharitiesBordeaux University Foundation100
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 CIC Bordeaux CIC1401 Université de Bordeaux Bâtiment Le Tondu - Case 41 146, Rue Léo Saignat
Address line 2 
Address line 3 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557579564 
Alternative phone number 
Fax number (incl. country code) 
Email address plateforme.bpe@u-bordeaux.fr
Public Enquiries
Title Professor 
Last name Gulmez 
First name Sinem Ezgi 
Address line 1Service de Pharmacologie CIC Bordeaux CIC1401 Université de Bordeaux Bâtiment Le Tondu - Case 41 146, Rue Léo Saignat 
Address line 2 
Address line 3 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557579564 
Alternative phone number 
Fax number (incl. country code) 
Email address plateforme.bpe@u-bordeaux.fr 
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