Status: Finalised First registered on: 13/06/2014
Last updated on: 24/11/2022
1. Study identification
EU PAS Register NumberEUPAS6769
Official titleStudy of Acute Liver Transplant-III: Prospective study of drug-exposed acute liver failure (ALF) in European liver transplant centers
Study title acronymSALT-III
Study typeObservational study
Brief description of the studyThe first SALT (Study of Acute Liver Transplant) study was a retrospective, multicentre, multi-country study of drug-exposed ALF registered for liver transplantation (ALFT), over the years 2005-2007. In the 52 contributing centres in seven participating European countries, 9479 patients were registered for transplantation, 600 for ALF, of which 302 without clinical aetiology were exposed to a drug within 30 days, the most commonly found being paracetamol, even without overdose. The SALT-I study created a network of these liver transplant centres in seven European countries. It also accumulated a considerable body of data on drug-exposed acute liver failure in Europe. The main objective of SALT-I concerned only the risks associated with NSAIDs. The SALT-II study extended the retrospective part of SALT to 2008-2013, thus increasing its power. In the 21 French contributing centres, 559 ALFT patients were identified, of which 214 without clinical aetiology exposed to a drug within 30 days, the most commonly found being paracetamol, even without overdose (as for SALT-I). This SALT-III study took advantage of this network of liver transplantation centres to do a prospective case-population surveillance of liver transplantations for drug-related ALF. The prospective nature of the SALT-III study had to allow for better quality data acquisition for drug-related liver transplantation, within a systematic alert system. The objective was to build a surveillance network of liver transplant centres in France that provide real-time assessment of emerging risks related to drugs newly introduced to the market, allowing for earlier signal identification of a major drug-related public health issue. SALT-III was conducted in 17 French liver transplantation centres over the years 2015-2016. Because of difficulties for including prospectively eligible patients (emergency medical care), it was decided to retrospectively include eligible ALFT patients not identified in time.
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 MOORE
First name Nicholas
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?17

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 collection01/07/201403/12/2014
Start date of data analysis31/01/2018
Date of interim report, if expected26/05/2015
Date of final study report30/11/201729/05/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
CharitiesL’Agence nationale de sécurité du médicament et des produits de santé (ANSM)100
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name MOORE
First name Nicholas
Address line 1Plateforme Bordeaux PharmacoEpi, 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)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
Email address nicholas.moore@u-bordeaux.fr
Public Enquiries
Title Professor 
Last name MOORE 
First name Nicholas 
Address line 1Plateforme Bordeaux PharmacoEpi, 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)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
Email address nicholas.moore@u-bordeaux.fr 
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