The Consorci Institut D'Investigacions Biomediques August Pi i Sunyer (IDIBAPS) is a public research centre dedicated to translational research in the field of biomedicine. Its mission is to integrate state of the art basic research and quality clinical research. Founded in 1996, IDIBAPS is formed by the Government of Catalonia, the University of Barcelona's Faculty of Medicine (UB), the Hospital Clínic de Barcelona (HCB) and the Institut d'Investigacions Biomèdiques de Barcelona of the Spanish Council for Scientific Research (IIBB-CSIC). HCB is the linked third party of IDIBAPS within LIVERHOPE.

The role of the team based at IDIBAPS is to coordinate the Liverhope project.

Main contact: Pere Ginès

The Hepatology Unit of Hospital Beaujon is one of the largest units dedicated to liver and biliary tract diseases in Europe. It is affiliated to University Paris Diderot and several research units (INSERM U1149, and others). It is also integrated in DHU UNITY, a consortium dedicated to educational activity and research in the fields of uncommon / refractory diseases of the liver, pancreas and gut. The Hepatology Unit of Hospital Beaujon has a more than 3 decades experience in research in liver diseases with national and international cooperation inside and outside Europe.

HB well be directly involved in the inclusion of patients screening during follow-up, implementation of data and analysis of results, clinical trial management tasks (regulatory submission according to national requirements, local monitoring, and local project management)

The role of the team based at IDIBAPS is to coordinate the Liverhope project.

Main contact: Francois Durand

UCL has a global reputation for excellence in research and is committed to delivering impact and innovations that enhance the lives of people in the UK, across Europe and around the world.

UCL is consistently placed in the global top 20 across a wide range of university rankings (currently 4th in the QS World University Rankings with a score of 98.9). Furthermore, the Thomson Scientific Citation Index shows that UCL is the 2nd most highly cited European university and 14th in the world.

UCL, in cooperation with the other Partners, will be involved in the screening and enrolment of patients for the 2 studies (on safety and on efficacy) WP2 and WP3 Furthermore, UCL will be involved in the collection and storage of samples. UCL has the necessary teams available with the experience and expertise to undertake these tasks within the project.

Main contact: Pajiv Jalan

The Department of Internal Medicine I of the University of Bonn has as main areas of experience are liver fibrosis with portal hypertension and complications such as ACLF.

This center is part of the Europe-wide CLIF-consortium investigating chronic liver failure, e.g. CANONIC study (http://www.clifconsortium.com). Especially ACLF is one area of expertise of this center, demonstrated by the participation in the CANONIC and INFECIR-2 study.

UKB, in cooperation with the other Partners, will be involved in the screening and enrolment of patients for the 2 studies (on safety and on efficacy) WP2 and WP3, trial management tasks in the German recruiting site involved in the project: regulatory submission according to national requirements, local monitoring, local pharmacovigilance, and local project management. Furthermore, UKB will be involved in the collection and storage of samples. UKB has the necessary teams available with the experience and expertise to undertake these tasks within the project.

Main contact: Jonel Trebicka

The University of Padua (UNIPD), founded in 1222, plays an important role in scholary and scientific research at both European and world level. UNIPD fosters and sustains an environment that facilitates the highest quality scholarship and research, providing leadership in setting research goals for the University, developing and implementing strategies for achieving research goals, capitalizing on the interdisciplinary strength of University research centres, and ensuring that the research infrastructure is robust and responsive to the expanding and ever-changing needs of researchers. Currently, UNIPD has 32 Departments, and 72 Research and Service Centres. The International Research Office offers a series of services to the University researchers involved in or applying for EU funded projects.

UNIPD, in cooperation with the other clinical Partners, will be involved in the screening and enrolment of patients for the 2 studies (on safety and on efficacy) WP2 and WP3. Furthermore, UNIPD will be involved in the collection and storage of samples. UNIPD has the necessary teams available with the experience and expertise to undertake these tasks within the project.

Main contact: Paolo Angeli

The “AOU Città della Salute e della Scienza di Torino” is one of the biggest University Hospitals in Europe. On 1st July 2012 a regional act unified four important Regional Hospitals and formed our City of Science and Health composed of Molinette Hospital, Sant’Anna Hospital, Regina Margherita Hospital and CTO Hospital.

Selection of patients for LIVERHOPE project, their inclusion in the study, follow-up of their clinical and laboratory outcomes, collection and storage of blood samples required by the project, entry of data in eCRF.

Main contact: Carlo Alessandria

The Unit of Semeiotica Medica is a unit of Internal Medicine and is part of the Department of Medical and Surgical Sciences of the University of Bologna, Italy, within the Policlinico S. Orsola-Malpighi. The Unit consists of: 1) a regular ward with 34 beds; 2) a 10 bedded ward were planned admissions are made; these consist of patients affected by end-stage liver disease with acute decompensation or hepatocellular carcinoma, many of whom included in the waiting list for liver transplantation; 3) a Day-Hospital facility dedicated to patients with liver disease; 4) Outpatient Clinics, one of which specifically dedicated to patients with cirrhosis.

Our organization has acquired specific experience in the management of patients with liver cirrhosis and in the prevention and management of complications of this disease (ascites, bacterial infections, acute kidney inury, hepatic encephalopathy, hepatocellular carcinoma, gastrointestinal bleeding etc.). Our organization is part of the local liver transplantation program and is involved in the selection of candidate patients, their follow-up in the transplant waitlist, and the follow up of liver transplant recipients.

Our organization will be involved in the selection of patients to be enrolled in the LIVERHOPE project, their inclusion in the study, the follow-up of their clinical and laboratory outcomes, the collection of blood samples required by the project, the entry of data in eCRF.

Main contact: Mauro Bernardi

Vall d'Hebron Research Institute (VHIR) is a public sector institution that promotes and develops innovative biomedical research at the University Hospital Vall d'Hebron (Universitat Autònoma de Barcelona). VHIR is oriented towards finding solutions to the health problems of the citizens and has the will to contribute to the scientific, educational, social and economic development within its area of competence.

Liver disease research group at the VHIR, has a long-standing expertise in clinical research in hepatology, including viral hepatitis, hepatic cirrhosis and liver transplantation. We have participated in clinical trials in ascitis (paracentesis, albumin use, antibiotic prophylaxis) for more tan 20 years. In this year, the group is participating in 6 active projects in relation to hepatic cirrhosis, 4 founded by Spanish Ministry of Science and Innovation Government, one founded by European Comission and one by National Institute of health of USA.

Our organization (Vall d’Hebron University Hospital-Vall d’Hebron Institut de Recerca), will be involved in the screening and enrollment of patients for the 2 following studies: WP 2 (safety and tolerability of oral simvastatin and rifaximin in patients with cirrhosis) and on efficacy) WP3 (clinical trial to evaluate safety and efficacy of oral simvastatin and rifaximin to prevent development of ACLF in patients with decompensated cirrhosis). Trial management tasks at VHIR: they will support the leading CTU for preparation of documentation to be submitted to the local ethics committee and they will perform local monitoring, pharmacovigilance, and project management.Furthermore, our organization will be involved in the the follow-up of their clinical and laboratory outcomes, collection and storage of samples and entry of data in the eCRF. Vall d’Hebron Hospital has the necessary teams available with the experience and expertise to undertake these tasks within the project.

Main contact: Victor Vargas

The Academic Medical Center (AMC) is one of the foremost research institutions in the Netherlands, as well as one of its largest hospitals (7,000 employees). The AMC complex houses the university hospital and the faculty of medicine of the University of Amsterdam (UvA) as well as the Emma Children’s Hospital, the Netherlands Institute for Neuroscience, the medical department of the Royal Tropical Institute and the Amsterdam Institute for Global Health and Development. During the next few years, the Spinoza Centre for Neuroimaging building will arise next to AMC.

AMC, in cooperation with the other Partners, will be involved in the screening and enrolment of patients for the 2 studies (on safety and on efficacy) WP2 and WP3 Furthermore, AMC will be involved in the collection and storage of samples. UKB has the necessary teams available with the experience and expertise to undertake these tasks within the project.

In addition, AMC will be responsible for all trial management tasks in the Dutch recruiting site involved in the project: regulatory submission according to national requirements, local monitoring, local pharmacovigilance, and local project management. These tasks will be performed by members of the CTU-AMC, a multidisciplinary team formed by clinical research associates (CRA), clinical trial assistants (CTA) and project managers.

Main contact: U. Beuers

The European Clinical Research Infrastructure Network (ECRIN, www.ecrin.org) is a sustainable, not-for-profit, distributed infrastructure with the legal status of a European Research Infrastructure Consortium (ERIC). ECRIN provides support to facilitate the development and implementation of multinational clinical research projects in Europe.

Through its Core Team based in Paris and its European Correspondents based in countries, ECRIN brings together national networks of academic clinical research infrastructures (see next section). These infrastructures are composed of Clinical Trials Units (CTU) and/or Clinical Research Centres (CRC) located in the main national universities and hospitals. The staff working in these units are experienced and professional, and are used to working with investigators and are very familiar with the local and national research environment.

ECRIN-ERIC is based on the connection of clinical research centres / clinical trials units organized as national networks and hubs in each country. Each national network (final service provider) is able to participate in the management of clinical trials through the provision of local services (including ethical and regulatory submissions, adverse event reporting, monitoring), in any disease area and for any category of clinical research.

Main contact: Joaquín Sáez-Peñataro

CRES, standing for Centre de Recerca en Economia i Salut or Centre for Research in Health and Economics, is a research centre of Universitat Pompeu Fabra (UPF). It was officially cofounded by Professors Guillem López-Casasnovas and Vicente Ortún Rubio in 1996. Its mission is to be a reference research centre in Spain and Europe in health economics. CRES aims at offering response, from the academics, to our health care systems' most important challenges. In practice, CRES has largely developed its research in a variety of topics including the evaluation of pharmaceutical and health care management policies. CRES has developed its research and training activity with the support of competitive funding (International, European or national wide) and by means of reaching several agreements with a diversity of institutions, including the Spanish Health Ministry, the Catalan Health Department, Obra Social "la Caixa", Almirall, Bertelssman Stiftung, Merck Foundation, BBVA Foundation, Farmaindustria, ANEFP, IMS, Novartis, Bayer, GlaxoSmithkline S.A., Merck, Sharp & Dohme Spain, S.A., among others.

A health economic impact analysis included in the Work Package 5 will be performed by CRES-UPF (Centre for Research in Health and Economics).

Main contact: Miquel Serra Burriel

Anaxomics is a privately owned SME established in Barcelona in 2007 as a life science service provider for drug discovery, pre-clinical and clinical development. Anaxomics offers a unique combination of cutting-edge systems biology solutions and long-time expertise in pharmaceutical and clinical research. Anaxomics has developed proprietary technologies for building and modelling biological networks, along with hand-curated databases that relate adverse events and indications with their molecular effectors. The Therapeutic Performance Mapping System (TPMS) integrates biological, pharmaceutical and medical knowledge into systems biology mathematical models that can explain observed phenotypes and translate the system understanding into actionable results and solutions in drug discovery and clinical setting. The Management Team of the Company has more than 20 years of experience in the field of drug discovery and clinical development. Anaxomics is supported by Scientific Advisors providing high-level scientific insight; it includes renowned scientists in the field of Systems Biology and Drug Discovery: P. Aloy, PhD (ICREA Research Professor and Researcher at IRB Barcelona) and J. Bigorra MD, PhD, (Director of Innovation at the Hospital Clínic de Barcelona). Committed to excellence in science – Anaxomics was finalist for the 2011 Red Herring Top 100 Innovative European Company Award, 4th place worldwide in IMPROVER challenge 2012 and has participated in 9 research consortiums under the EU 7th Framework Program.

Anaxomics brings to the project is expertise in systems biology. Within WP4, it will exploit the capabilities of its platform and extend them to evaluate new prognostic biomarkers of cirrhosis progression and predictive biomarkers of treatment response. The stratification patterns identified based on systems biology analysis will also support the statistical analysis of the clinical trial results.

Main contact: Judith Farrés

Alfasigma is an Italian pharmaceutical company founded after the merge of Alfa Wassermann (previous LIVERHOPE Consortium partner) and Sigma-Tau groups.

Inheriting the high values and acknowledged expertise of the former companies and putting the focus on the potential and on specialisation, Alfasigma is one of the top five operators in the pharmaceutical sector in Italy. Developed in its own research laboratories, one of Alfasigma’s most successful drugs is Rifaximin-α, a compound used for the treatment of gastrointestinal inflammatory and infectious diseases, patented by Alfa Wassermann.

AW will be in charge of the supply of the clinical trial material of rifaximin EIR and its placebo, will supervise the clinical trials and will guarantee the project exploitation and follow up.

Main contact: Raffaella Tacchi

The European Foundation for the Study of Chronic Liver Failure (EF-CLIF) was created with the aim of designing, promoting and supporting studies on the mechanism, prevention and treatment of liver cirrhosis and its complications; particularly, acute-on-chronic liver failure.

The EF-CLIF is a non-profit organization committed to fight against a disease that represents the seventh most common cause of death in Western Europe.

In the origin of the EF-CLIF lies the European Association for the Study of the Liver – Chronic Liver Failure (EASL-CLIF) Consortium. An independent entity, the Consortium, with almost a hundred hospitals in 25 countries, is an important instrument for carrying out observational and therapeutic studies on large series of patients.

Expert collaboration in the elaboration of the development plan, in the design of clinical studies and in the writing of clinical protocols and reports. Senior statistician participating in the elaboration of study designs, study protocols and statistical analysis plans, as well as in data analyses.

Senior data manager participating in the Elaboration of the study protocol, eCRF design, Development of Database (DB) clinical trial data specifications, edit rules/checks, query logic and data validations, Development of Data Management Plan (DMP), Creation of EDC user guides, Reconciliation AE/SAE data in Safety DB and/or other Data Management DB.

Main contact: Vicente

ELPA emerged from a desire amongst European liver patient groups to share their experiences of the often very different approaches adopted in different countries. In June 2004, 13 patient groups from 10 European and Mediterranean Basin countries met to create the association. ELPA was formally launched in Paris on April 14th 2005 during the annual conference of the European Association for the Study of the Liver (EASL) and now.

ELPA's aim is to promote the interests of people with liver disease and in particular: to highlight the size of the problem; to promote awareness and prevention; to address the low profile of liver disease as compared to other areas of medicine such as heart disease; to share experience of successful initiatives; to work with professional bodies such as EASL and with the EU to ensure that treatment and care are harmonized across Europe to the highest standards.

The main activities of ELPA will be:
• Raising attention in society medical and political fora, for increasing the interest of the project topic
• Increase awareness about the importance of development specific strategies for treatment of patients with chronic liver diseases
• Take the patients' view
• Raise attention about how to perform access to appropriate care
• Development of strategies for early diagnosis and management of chronic liver diseases in European countries.

Main contacts: Marko Korenjak

ALTA S.r.l. (www.altaweb.eu) is a service provider company with experience in project engineering and management of the publicly funded research projects. Founded in 1998 by Aldo Tagliabue, ALTA has been involved in several projects during the 5th FP. From the 6th Framework Programme, ALTA has been involved in the administrative management of several Integrated Projects, Marie Curie EST Project, Marie Curie IAPP, STREP, Network of Excellence. During the FP7, ALTA has been involved as partner for management and dissemination activities in 14 research collaborative projects (Theme: Health), 1 IMI project, 1 project for the benefit of SMEs, several projects of the people programme.

Working in close contact with the Project Coordinator, the specific contribution of ALTA to this project will be in WP1 Project Management and coordination; WP6 Communication, dissemination and exploitation.

In details, the ALTA’s main tasks will be: 1) check the progress of the administrative work; 2) coordinate the administrative bodies of the different participants’ institutions; 3) coordinate the preparation of reports; 4) develop and implement plans for communication and for enhancing the visibility of the consortium; 5) support coordinator in organizing project meetings; 6) coordinate the dissemination and communication activities.

Main contact: Laura Maccari

The Universitaetsklinikum Frankfurt (Goethe University Frankfurt, GUF) is known for the excellence in research especially in cardiovascular research, pharmacology and hepatology.

The Medical Faculty of Goethe University Frankfurt offers a large variety of facilities to support the research in this key area of the GUF. The Department of Internal Medicine I of the GUF, has an important role in the region, since it offers the full spectrum of therapeutic approaches in liver patients reaching form hepatitis treatment over TIPS to liver transplantation. Especially in the last years this Department has been world leading for the development of the novel hepatitis C treatments (direct antiviral agents, DAA), which finally can heal hepatitis C virus infection. The Section of Translational Hepatology, recently established by Prof. Dr. Jonel Trebicka within the Department of Internal Medicine I participates in the collaborative research centre TRR 57 (http://www.sfbtrr57.de) funded by Deutsche Forschungsgemeinschaft with the title: “Organ Fibrosis: From Mechanisms of Injury to Modulation of Disease” since 2009. The section is part of the Europe wide CLIF-consortium (http://www.clifconsortium.com) investigating chronic liver failure.

GUF, in cooperation with the other Partners, will be involved in the screening and enrolment of patients for the 2 studies (on safety and on efficacy) WP2 and WP3, trial management tasks in the German recruiting site involved in the project: regulatory submission according to national requirements, local monitoring, local pharmacovigilance, and local project management.

Furthermore, GUF will be involved in the collection and storage of samples. GUF has the necessary teams available with the experience and expertise to undertake these tasks within the project.

Main contact: Jonel Trebicka

In 1963, UZH created the first chair and institute of Public Health (then Social and Preventive Medicine) in Switzerland. Professor Meinrad Schär († 2007), the former deputy director of the Swiss Office of Public Health, served as the first chair and director of the institute until 1988. Prof. Felix Gutzwiller followed and led the institute until 2013. Prof. Gutzwiller was instrumental in creating close ties between the institute and the population of the Canton of Zurich through the UZH Travel Clinic and the Prevention and Health Promotion unit. During his term, the institute focused on physical, psychological, and social determinants of health and substantially expanded in the areas of epidemiology and biostatistics. In 2013, Prof. Milo Puhan was appointed as Professor of Epidemiology and Public Health and director of the institute. The institute performs Health Technology Assessments (HTAs) for the Swiss Medical Board, in cooperation with units at the Universities of Basel and Geneva. Our contributions focus on the health economic characteristics (cost-effectiveness, budget impact) of medical strategies. Another part of the project is the development of HTA methodology appropriate for Switzerland.

The main task of the project is to perform health-economic analyses to demonstrate the enhanced benefit/cost ratio of the new therapy into clinical routine: 1. Cost-effectiveness analysis. 2. Budget Impact analysis. 3. Univariate & probabilistic sensitivity analysis.

Main contact: Miquel Serra Burriel

INN-ACTA (www.innovationacta.eu) is a company specialized in managing H2020 project proposals and actions. INN-ACTA Grants Managers are highly qualified and have acquired a renowned competence in grants management and dissemination activities over 20 year experience in EU funded projects. In the course of the different framework programmes, INN-ACTA’s grant managers have indeed participated in more than 40 EU funded projects, including Collaborative Projects in Health Programmes, Coordination and Supporting Actions, IMI projects and Marie Curie Actions. So far, Innovation Acta has been granted eight projects: NECESSITY- IMI project, INTEGRATA - Marie Skłodowska-Curie ITN, RESTORE - CSA project, RESHAPE - RIA Health project, INsTRuCT - Marie Skłodowska-Curie ITN; HDM-FUN – RIA Health project, LiverScreen – RIA Health project, EDUC8 - Marie Skłodowska-Curie ITN. INN-ACTA capitalizes the strong expertise reached by its staff in grants management, dissemination activities (such as printed materials flyers, brochures, periodic newsletters, project websites and videos), training activities, organization of meetings, conferences, workshops and Project events.

The main tasks in the project include leading WP6 about Communication, dissemination and exploitation and working in close contact with the Project Coordinator to support Project Management and coordination.

Main contact: Paola Cesaroni