Identification of drug-induced liver injury (DILI) cases in Spain, a national DILI registry (Spanish DILI Registry)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48726
• EU PAS number:
  EUPAS3145
• Study ID:
  48726
• Official title and acronym:
  Identification of drug-induced liver injury (DILI) cases in Spain, a national DILI registry (Spanish DILI Registry)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  This is a national study that aims to identify drug-induced liver injury (DILI) cases in Hepatology and Clinical Pharmacology units in Spain. This study contains more than 50 clinical units that has sent potential hepatotoxicity cases to the coordinating center in Malaga (using a structured protocol), where the cases are diagnosed as being or not being drug-induced liver injury cases based on the corresponding clinical data acquired by the physician in charge at the collaborating unit. Clinical and demographical data are entered in to a common data base to be used for epidemiological and causality assessment studies. With the patients consent biological samples are also collected, stored in a biobank and used in biomarker identification studies
• Study status:
  Ongoing

Research institutions and networks

Institutions

Spanish DILI Registry

Spain

Networks

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd)

Study timelines

Date when funding contract was signed

Actual: 01/06/1999

Study start date

Actual: 03/01/1994

Data analysis start date

Actual: 01/06/2001

Date of final study report

Planned: 30/06/2025

Sources of funding

EU institutional research programme

Other

More details on funding

Agencia Española del Medicamentos y Productos Sanitarios, FISS, MINIM, SAFE-T

Regulatory

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