Summary

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 recruited 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. 

The UK trial manager for the Liverhope projects moved to the Nottingham Clinical Trials Unit and the UK trial management activities are now being undertaken by that Unit.    

For more information, please see Liverhope website  

Contact

Kathryn Starr (Nottingham Clinical Trials Unit); ms-liverhope@exmail.nottingham.ac.uk

Status

Safety study - Completed

Efficacy study - Ongoing