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DECOMPENSATED CIRRHOSIS: IDENTIFICATION OF NEW COMBINATORIAL THERAPIES BASED ON SYSTEMS APPROACHES

Project description

Combinatorial therapy for decompensated cirrhosis

Cirrhosis mortality is mainly associated with cirrhosis decompensation (development of ascites, hepatic encephalopathy, gastrointestinal haemorrhage, and progression to acute-on-chronic liver failure (ACLF). Despite multiple treatments, mortality in patients with decompensation of cirrhosis remains high. The EU-funded DECISION project aims to understand the pathophysiology of decompensation of cirrhosis leading to ACLF or death, and to decrease patient mortality. The project will study the pathophysiology of decompensation of cirrhosis by integrating results of high-throughput multi-omic profiling with comprehensive clinical data from 2 200 fully characterised patients with available standardised biological samples. DECISION will help to identify novel combinatorial therapies to prevent high mortality for patients with decompensation of cirrhosis. Finally, researchers will optimise these therapies in new animal models and then test the best combination in high-risk patients in a Phase II clinical trial.

Objective

In 2013, cirrhosis was responsible for 1.2 million deaths worldwide. This mortality is mainly due to cirrhosis decompensation, i.e. development of ascites, hepatic encephalopathy, and/or gastrointestinal hemorrhage, and its progression to acute-on-chronic liver failure (ACLF). Patients with decompensated cirrhosis receive many treatments such as intravenous and oral absorbable antibiotics, oral non-absorbable antibiotics, albumin, proton-pump inhibitors, laxatives, diuretics, betablockers, vasoconstrictors, statins, anticoagulants, steroids and antiviral agents. Despite these multiple treatments, ACLF or mortality in patients with decompensation of cirrhosis remains high (15% at day 28, 28% at day 90) because of large interindividual variability in precipitating events, in clinical presentation and in response to treatment. This heterogeneity calls for treatment personalization according to underlying mechanisms. The objective of DECISION is to enhance our understanding, at systems level, of the pathophysiology of decompensation of cirrhosis leading to ACLF or death to decrease patients’ mortality at day 28.
First, DECISION will improve our knowledge of the pathophysiology of decompensation of cirrhosis by integrating results of high-throughput multi-omic profiling with comprehensive clinical data from 2,200 fully characterized patients (more than 8,600 time points) with available standardized biological samples. Second, we will identify novel combinatorial therapies for patients with decompensation of cirrhosis to prevent death. We will refine these therapies in new and/or optimized animal models and then test the best combination in high risk patients in a phase II clinical trial built in DECISION. Third, we will develop 2 tests: one predicting outcome of patients with decompensation of cirrhosis when treated with standard treatment (prognostic test); and the other identifying patients who will respond to the novel combinatorial therapy (test for response).

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Programme(s)

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Topic(s)

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RIA - Research and Innovation action

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Call for proposal

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(opens in new window) H2020-SC1-BHC-2018-2020

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Coordinator

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

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 1 305 833,45
Address
TRAVESSERA DE GRACIA 11, 7TH FLOOR
08021 Barcelona
Spain

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Region
Este Cataluña Barcelona
Activity type
Research Organisations
Links
Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 1 305 837,65

Participants (25)

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