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SIMVASTATIN AND RIFAXIMIN AS NEW THERAPY FOR PATIENTS WITH DECOMPENSATED CIRRHOSIS

SIMVASTATIN AND RIFAXIMIN AS NEW THERAPY FOR PATIENTS WITH DECOMPENSATED CIRRHOSIS

Objective

Liver cirrhosis is a very common chronic disease and one of the leading causes of death in European. Moreover, cirrhosis has a marked impact in patients quality of life and represents a major burden for health systems. Treatment of cirrhosis is currently based on symptomatic management of complications and has not changed substantially in the last 20 years. There is an unmet need for therapies that target the pathobiology of cirrhosis.
The objective of LIVERHOPE project is to evaluate a novel therapeutic strategy for patients with cirrhosis based on a combination of rifaximin and simvastatin, targeting the main pathophysiological mechanisms of disease progression , namely the impairment in the gut-liver axis and the persistent hepatic and systemic inflammatory response. This dual therapeutic approach is supported by preclinical data showing excellent and very promising results.
We will perform two randomized double-blind trials to investigate safety, tolerability and efficacy of combination of simvastatin plus rifaximin in patients with decompensated cirrhosis in 5 EU countries (285 patients will be enrolled in two trials in DE, ES, FR, IT, UK). The expected impact is to halt progression to acute-on-chronic liver failure, the main cause of death, to decrease complications of the disease, to reduce hospital readmissions, to improve cost-effectiveness of therapy. Our final aim is to improve patients quality-of-life and increase survival as patients‘ care is the core of LIVERHOPE. Within the project we will also investigate biomarkers of response to treatment and disease progression that can be useful in clinical practice for improving the treatment of patients. We will invest our effort also in communication and dissemination activities for increasing awareness about chronic liver diseases in European countries so that preventive measures can be established to decrease the burden of cirrhosis and reduce social stigmatization of patients with chronic liver diseases.
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Coordinator

CONSORCI INSTITUT D'INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYER

Address

Calle Rossello 149 Puerta Bjs
08036 Barcelona

Spain

Activity type

Other

EU Contribution

€ 1 768 896,50

Participants (17)

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ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

France

EU Contribution

€ 366 594

UNIVERSITY COLLEGE LONDON

United Kingdom

EU Contribution

€ 320 000

UNIVERSITAETSKLINIKUM BONN

Germany

EU Contribution

€ 178 153,08

UNIVERSITA DEGLI STUDI DI PADOVA

Italy

EU Contribution

€ 320 593,75

AZIENDA OSPEDALIERA CITTA DELLA SALUTE E DELLA SCIENZA DI TORINO

Italy

EU Contribution

€ 320 000

ALMA MATER STUDIORUM - UNIVERSITA DI BOLOGNA

Italy

EU Contribution

€ 320 000

FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA

Spain

EU Contribution

€ 342 867

Academisch Medisch Centrum bij de Universiteit van Amsterdam

Netherlands

EU Contribution

€ 396 525

ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK

France

EU Contribution

€ 643 064,36

UNIVERSIDAD POMPEU FABRA

Spain

EU Contribution

€ 58 750

ANAXOMICS BIOTECH, S.L.

Spain

EU Contribution

€ 223 875

ALFA WASSERMANN SPA

Italy

ALFASIGMA SPA

Italy

EU Contribution

€ 225 550

EUROPEAN FOUNDATION FOR THE STUDY OF CHRONIC LIVER FAILURE (EF-CLIF)

Spain

EU Contribution

€ 50 100

EUROPEAN LIVER PATIENTS ASSOCIATION

Belgium

EU Contribution

€ 100 000

ALTA RICERCA E SVILUPPO IN BIOTECNOLOGIE SRLU

Italy

EU Contribution

€ 190 382,50

JOHANN WOLFGANG GOETHE-UNIVERSITATFRANKFURT AM MAIN

Germany

EU Contribution

€ 173 448,81

Project information

Grant agreement ID: 731875

Status

Ongoing project

  • Start date

    1 January 2017

  • End date

    31 December 2021

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 5 998 800

  • EU contribution

    € 5 998 800

Coordinated by:

CONSORCI INSTITUT D'INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYER

Spain