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LIVERHOPE SIGNED

SIMVASTATIN AND RIFAXIMIN AS NEW THERAPY FOR PATIENTS WITH DECOMPENSATED CIRRHOSIS

Total Cost €

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EC-Contrib. €

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Partnership

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Project "LIVERHOPE" data sheet

The following table provides information about the project.

Coordinator
CONSORCI INSTITUT D'INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYER 

Organization address
address: CALLE ROSSELLO 149 PUERTA BJS
city: BARCELONA
postcode: 8036
website: http://www.idibaps.org/en_index.html

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Spain [ES]
 Project website http://www.liverhope-h2020.eu
 Total cost 5˙998˙800 €
 EC max contribution 5˙998˙800 € (100%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-SC1-2016-RTD
 Funding Scheme RIA
 Starting year 2017
 Duration (year-month-day) from 2017-01-01   to  2021-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    CONSORCI INSTITUT D'INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYER ES (BARCELONA) coordinator 1˙768˙896.00
2    ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK FR (PARIS) participant 643˙064.00
3    ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM NL (AMSTERDAM) participant 396˙525.00
4    ASSISTANCE PUBLIQUE HOPITAUX DE PARIS FR (PARIS) participant 366˙594.00
5    FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA ES (BARCELONA) participant 342˙867.00
6    UNIVERSITA DEGLI STUDI DI PADOVA IT (PADOVA) participant 320˙593.00
7    ALMA MATER STUDIORUM - UNIVERSITA DI BOLOGNA IT (BOLOGNA) participant 320˙000.00
8    AZIENDA OSPEDALIERA CITTA DELLA SALUTE E DELLA SCIENZA DI TORINO IT (TORINO) participant 320˙000.00
9    UNIVERSITY COLLEGE LONDON UK (LONDON) participant 320˙000.00
10    ALFASIGMA SPA IT (BOLOGNA) participant 225˙550.00
11    ANAXOMICS BIOTECH SL ES (BARCELONA) participant 223˙875.00
12    ALTA RICERCA E SVILUPPO IN BIOTECNOLOGIE SRLU IT (SIENA) participant 190˙382.00
13    UNIVERSITATSKLINIKUM BONN DE (BONN) participant 178˙153.00
14    JOHANN WOLFGANG GOETHE-UNIVERSITATFRANKFURT AM MAIN DE (FRANKFURT AM MAIN) participant 173˙448.00
15    EUROPEAN LIVER PATIENTS ASSOCIATION BE (BRUXELLES) participant 100˙000.00
16    UNIVERSIDAD POMPEU FABRA ES (BARCELONA) participant 58˙750.00
17    EUROPEAN FOUNDATION FOR THE STUDY OF CHRONIC LIVER FAILURE (EF-CLIF) ES (BARCELONA) participant 50˙100.00
18    ALFA WASSERMANN SPA IT (ALANNO PE) participant 0.00

Map

 Project 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.

 Deliverables

List of deliverables.
Communication material for patient associations, patients and families enrolled_I Demonstrators, pilots, prototypes 2020-03-17 14:18:44
Interim analysis report on cost-effectiveness and cost-utility, included budget impact analysis and sensivity analysis, both univariate and probabilistic Documents, reports 2020-03-17 14:18:44
Space for LIVERHOPE on the ELPA web sit Websites, patent fillings, videos etc. 2020-03-17 14:18:44
Presentation of LIVERHOPE at ELPA Symposium and possible other venue Demonstrators, pilots, prototypes 2020-03-17 14:18:44
Project web site Websites, patent fillings, videos etc. 2020-03-17 14:18:44
Initial dissemination plan Documents, reports 2020-03-17 14:18:44
Publications and material for communication (flyers, press release, videos, seminars, publications)_I Websites, patent fillings, videos etc. 2020-03-17 14:18:44
Project visual identity Documents, reports 2020-03-17 14:18:44

Take a look to the deliverables list in detail:  detailed list of LIVERHOPE deliverables.

 Publications

year authors and title journal last update
List of publications.
2018 Elisa Pose, Jonel Trebicka, Rajeshwar P. Mookerjee, Paolo Angeli, Pere Ginès
Statins: old drugs as new therapy for liver diseases?
published pages: , ISSN: 0168-8278, DOI: 10.1016/j.jhep.2018.07.019
Journal of Hepatology 2020-03-17
2019 Cristina Solé, Elsa Solà, Patricia Huelin, Marta Carol, Rebeca Moreira, Unai Cereijo, José‐Manuel Mas, Isabel Graupera, Elisa Pose, Laura Napoleone, Gloria dePrada, Adrià Juanola, Núria Fabrellas, Ferran Torres, Manuel Morales‐Ruiz, Judith Farrés, Wladimiro Jiménez, Pere Ginès
Characterization of inflammatory response in hepatorenal syndrome: Relationship with kidney outcome and survival
published pages: 1246-1255, ISSN: 1478-3223, DOI: 10.1111/liv.14037
Liver International 39/7 2020-03-17
2020 Elisa Pose, Laura Napoleone, Ahmed Amin, Daniela Campion, César Jimenez, Salvatore Piano, Olivier Roux, Frank Erhard Uschner, Koos de Wit, Giacomo Zaccherini, Carlo Alessandria, Paolo Angeli, Mauro Bernardi, Ulrich Beuers, Paolo Caraceni, François Durand, Rajeshwar P Mookerjee, Jonel Trebicka, Victor Vargas, Raúl J Andrade, Marta Carol, Judit Pich, Juan Ferrero, Gema Domenech, Marta Llopis, Fer
Safety of two different doses of simvastatin plus rifaximin in decompensated cirrhosis (LIVERHOPE-SAFETY): a randomised, double-blind, placebo-controlled, phase 2 trial
published pages: 31-41, ISSN: 2468-1253, DOI: 10.1016/s2468-1253(19)30320-6
The Lancet Gastroenterology & Hepatology 5/1 2020-03-17
2017 Elsa Solà, Pere Ginès
Pro: Acute-on-chronic liver failure
published pages: 1318-1324, ISSN: 1527-6465, DOI: 10.1002/lt.24812
Liver Transplantation 23/10 2020-03-17
2020 Núria Fabrellas, Marta Carol, Ester Palacio, Marites Aban, Tommaso Lanzillotti, Gea Nicolao, Maria Teresa Chiappe, Vanessa Esnault, Sabine Graf‐Dirmeier, Jeltje Helder, Andrea Gossard, Mireia Lopez, Marta Cervera, Lacey L. Dols, Elsa Solà, Elisa Pose, Paolo Caraceni, Victor Vargas, Carlo Alessandria, Ulrich Beuers, Jonel Trebicka, François Durand, Rajeshwar Mookerjee, Paolo Angeli, Marko Kore
Nursing care of patients with cirrhosis
published pages: , ISSN: 0270-9139, DOI: 10.1002/hep.31117
Hepatology 2020-03-17
2018 Pere Ginès, Shiv Sarin
More Than Meets the Eye in Using Interleukin 6 as a Marker of Inflammation and Prognostic Factor for Patients With Cirrhosis
published pages: 630-632, ISSN: 1542-3565, DOI: 10.1016/j.cgh.2017.12.031
Clinical Gastroenterology and Hepatology 16/5 2020-03-17
2017 Ruben Hernaez, Elsa Solà, Richard Moreau, Pere Ginès
Acute-on-chronic liver failure: an update
published pages: 541-553, ISSN: 0017-5749, DOI: 10.1136/gutjnl-2016-312670
Gut 66/3 2020-03-17
2018 Cristina Solé, Elisa Pose, Elsa Solà, Pere Ginès
Hepatorenal syndrome in the era of acute kidney injury
published pages: , ISSN: 1478-3223, DOI: 10.1111/liv.13893
Liver International 2020-03-17

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The information about "LIVERHOPE" are provided by the European Opendata Portal: CORDIS opendata.

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