SALT-II: Study of Acute Liver Transplant Prolongation and continuation of the SALT-I study “A study of drug-exposed acute liver failure (ALF) in European transplant centres”

Study identification

• EU PAS number:
  EUPAS5555
• Study ID:
  40867
• Official title and acronym:
  SALT-II: Study of Acute Liver Transplant Prolongation and continuation of the SALT-I study “A study of drug-exposed acute liver failure (ALF) in European transplant centres”
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The 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).
• Study status:
  Finalised

Research institutions and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

Bordeaux PharmacoEpi, University of Bordeaux

France

Study timelines

Date when funding contract was signed

Actual:20/12/2013

Study start date

Planned:01/07/2014

Actual:01/07/2014

Data analysis start date

Actual:12/02/2016

Date of interim report, if expected

Actual:27/11/2015

Date of final study report

Planned:30/12/2016

Actual:13/07/2016

Sources of funding

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

More details on funding

Bordeaux University Foundation

Regulatory

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