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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.

Call for proposal

H2020-SC1-2016-RTD
See other projects for this call

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 (18)

ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
EU contribution
€ 366 594
Address
3 Avenue Victoria
75000 Paris
Activity type
Research Organisations
UNIVERSITY COLLEGE LONDON
United Kingdom
EU contribution
€ 320 000
Address
Gower Street
WC1E 6BT London
Activity type
Higher or Secondary Education Establishments
UNIVERSITATSKLINIKUM BONN

Participation ended

Germany
EU contribution
€ 178 153,08
Address
Venusberg-campus 1
53127 Bonn
Activity type
Higher or Secondary Education Establishments
UNIVERSITA DEGLI STUDI DI PADOVA
Italy
EU contribution
€ 320 593,75
Address
Via 8 Febbraio 2
35122 Padova
Activity type
Higher or Secondary Education Establishments
AZIENDA OSPEDALIERA CITTA DELLA SALUTE E DELLA SCIENZA DI TORINO
Italy
EU contribution
€ 320 000
Address
Corso Bramante 88 90
10126 Torino
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
ALMA MATER STUDIORUM - UNIVERSITA DI BOLOGNA
Italy
EU contribution
€ 320 000
Address
Via Zamboni 33
40126 Bologna
Activity type
Higher or Secondary Education Establishments
FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA
Spain
EU contribution
€ 342 867
Address
Passeig Vall D Hebron 119-129 Edificio De Recerca
08035 Barcelona
Activity type
Research Organisations
ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM
Netherlands
EU contribution
€ 396 525
Address
Meibergdreef 15
1105AZ Amsterdam
Activity type
Higher or Secondary Education Establishments
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
EU contribution
€ 643 064,36
Address
5 Rue Watt
75013 Paris
Activity type
Research Organisations
UNIVERSIDAD POMPEU FABRA

Participation ended

Spain
EU contribution
€ 48 688,66
Address
Placa De La Merce, 10-12
08002 Barcelona
Activity type
Higher or Secondary Education Establishments
ANAXOMICS BIOTECH SL
Spain
EU contribution
€ 223 875
Address
Calle Diputacio 237, P 1 Pta 1
08007 Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ALFASIGMA SPA
Italy
EU contribution
€ 225 550
Address
Via Ragazzi Del 99 5
40133 Bologna
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EUROPEAN FOUNDATION FOR THE STUDY OF CHRONIC LIVER FAILURE (EF-CLIF)
Spain
EU contribution
€ 50 100
Address
Travessera De Gracia 11, 7Th Floor
08021 Barcelona
Activity type
Research Organisations
EUROPEAN LIVER PATIENTS ASSOCIATION
Belgium
EU contribution
€ 100 000
Address
Rue De La Loi 235/27
1040 Bruxelles
Activity type
Other
ALTA RICERCA E SVILUPPO IN BIOTECNOLOGIE SRLU

Participation ended

Italy
EU contribution
€ 153 101,10
Address
Via Fiorentina 151
53100 Siena
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
JOHANN WOLFGANG GOETHE-UNIVERSITAET FRANKFURT AM MAIN
Germany
EU contribution
€ 173 448,81
Address
Theodor W Adorno Platz 1
60323 Frankfurt Am Main
Activity type
Higher or Secondary Education Establishments
UNIVERSITAT ZURICH
Switzerland
EU contribution
€ 10 061,34
Address
Ramistrasse 71
8006 Zurich
Activity type
Higher or Secondary Education Establishments
INNOVATION ACTA S.R.L.
Italy
EU contribution
€ 37 281,40
Address
Via D.a. Azuni, 9
00196 Roma
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)