ALIVER

PI: Rajiv Jalan
(University College, London, UK).

Funder/Promoter: European Commission H2020

This is a European multicentre, two phase project on the role of a new artificial liver support system (DIALIVE) in patients with ACLF. The first phase consists in a randomized controlled study, to evaluate the safety and performance of The DIALIVE Liver Dialysis Device in patients with ACLF versus standard of care. This trial is currently ongoing.

After successful completion of the DIALIVE Safety & Performance study, a second phase is planned, consisting of a randomized controlled trial of 100 patients, to assess the efficacy of the DIALIVE versus standard medical therapy in ACLF patients. The main aim-point is 3-month survival.

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CARBALIVE

PI: Rajiv Jalan
(University College, London, UK).

Funder/Promoter: European Commission H2020

The aim of the CARBALIVE project is to further develop and validate a novel nanoporous carbon adsorbent (Yaq-001), capable of removing bacterial endotoxin and other metabolic toxins relevant to the progression of bacterial translocation and endotoxemia, in patients with cirrhosis and ACLF and those with non-alcoholic fatty liver disease. A first randomized controlled trial to assess treatment Safety is scheduled to start in January 2019.

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LIVERHOPE

PI: Pere Ginès
(Hospital Clínic, Barcelona, Spain).

Funder: European Commission H2020

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.

It includes two clinical trials. The first one is a small comparative study (still ongoing) to assess safety. In a second phase, a double-blind randomized clinical trial will compare the explored treatment versus placebo and efficacy in preventing ACLF development and improvement survival in patients with decompensated cirrhosis.

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HEPASTEM

PI: Frederik Nevens
(UZ Gasthuisberg, Leuven, Belgium).

Promoter: PROMETHERA

Promethera Biosciences is a start-up pharmaceutical company from Leuven that develops innovative therapies for the treatment of liver diseases. The HEPASTEM study is a phase-two clinical trial, aimed at assessing the safety and efficacy of heterologous human adult liver-derived progenitor cells in the management of patients with ACLF.

LIPOSOMAL PERITONEAL DIALYSIS FOR THE MANAGEMENT OF HEPATIC ENCEPHALOPATHY

PI: Jonel Trebicka
(University of Bonn, Germany).

Funder/Promoter: Versantis

Versantis is a start-up pharmaceutical company from Zurich that develops innovative therapies based on lipid microvesicles. This study consists of a two-phase clinical investigation, aimed at assessing the safety and efficacy of ammonia scavenging microvesicles (liposomes) administered intraperitoneally in the management of patients with cirrhosis and hepatic encephalopathy.

The first-in-man phase I trial started in 2019 and already included three patients, which were successfully treated. The treatment was very well tolerated and first data seem very promising and we look forward to the next cohorts of this study.