This Horizon 2020 EU funded project seeks to evaluate simvastatin and rifaximin as new therapy for patients with decompensated cirrhosis. This European multi-centre project is clinically led by Institut D’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) and managed in conjunction with the European Clinical Research Network (ECRIN). CHaRT are working with UCL and the Royal Free Hospital, London on behalf of ECRIN to manage the study in the UK. The project has two phases, LIVERHOPE_safety and LIVERHOPE_efficay.
LIVERHOPE_SAFETY will aim to address the safety and tolerability of the combination of simvastatin plus rifaximin in patients with decompensated cirrhosis. It will recruit 45 patients throughout the EU over three months and will follow participants for three months.
LIVERHOPE_EFFICACY is a double-blind, placebo-controlled trial on the effect of simvastatin plus rifaximin in halting disease progression and the development of acute-on-chronic liver failure (ACLF) in patients with decompensated cirrhosis. It will recruit 240 participants over 12 months. Participants will receive study medication for one year and will be followed during this time and for three months post-treatment.
CHaRT are no longer involved in the trial management activity for LIVERHOPE.
Contacts
- CHaRT email; chart@abdn.ac.uk
Status
Ongoing - Safety study/Completed and Efficacy study/OngoingPublications
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, Ferran Torres, Patrick S Kamath, Juan G Abraldes, Elsa Solà, Pere Ginès, Safety of two different doses of simvastatin plus rifaximin in decompensated cirrhosis (LIVERHOPE-SAFETY): a randomised, double-blind, placebo-controlled, phase 2 trial, The Lancet Gastroenterology & Hepatology, Volume 5, Issue 1, 2020, Pages 31-41, ISSN 2468-1253