Prospective European Drug-Induced Liver Injury Registry
Financed by: The European Association for the Study of the Liver
Programme: EASL REGISTRY RESEARCH GRANTS PROGRAMME 2014
Rol in the project: Coordinator
Duration: March 2014 to March 2016
Contact: Andrade Bellido, Raúl J.
Implementation Centre: Virgen de la Victoria University Hospital
Research group of IBIMA involved: Hepatogastroenterology, Pharmacology, and Translational Clinical Therapeutics
ABSTRACT
There are no evidence-based treatments for DILI; rarity of the condition and heterogeneity of the manifestations prevents the conception and successful completion of clinical trials. Multi-centre Pro-Euro-DILI registry will provide both the infra-structure to conduct clinical trials, and also sufficient number of well characterised patients to evaluate the efficacy of novel anti-cholestatic agents in the resolution of DILI.Aims:
- To set-up a multi-national registry of patients with idiosyncratic DILI enrolled prospectively with in-depth phenotyping including details of drug dose, duration, concomitant medications, host demography, comorbidity including insulin sensitivity (homeostatic model assessment; HOMA), as well as course of the reaction.
- To enrol similarly well-characterised control group of people who are exposed to medications matched for those implicated in DILI.
- To collect biological samples (blood, urine, stool and liver biopsy) from patients with idiosyncratic DILI through the course (at onset and follow-up) of the event as well as controls.
Partners
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- Instituto de Investigación Biomédica de Málaga (IBIMA)
- Nottingham Digestive Diseases Centre
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