LIVERHOPE EFFICACY
Research type
Research Study
Full title
Efficacy of the combination of simvastatin plus rifaximin in patients with decompensated cirrhosis to prevent ACLF development: a multicenter, double-blind, placebo controlled randomized clinical trial.
IRAS ID
252177
Contact name
Raj Mookerjee
Contact email
Sponsor organisation
IDIBAPS
Eudract number
2018-001698-25
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Cirrhosis is the final stage of liver diseases, and currently, there is no effective treatment, with liver transplantation being the only curative solution in selected patients. As the number of donor organs for liver transplantation is limited and criteria for transplantation are strict, the current management of cirrhosis consists of treating its complications.
However, there is no effective therapy that prevents or cures the disease itself.
Rifaximin is an antibiotic that acts in the gastrointestinal tract. It is poorly absorbed to the general circulation and has low toxicity and good tolerability. It is currently approved for use in patients with cirrhosis to prevent recurrent hepatic
encephalopathy. Rifaximin decreases the transit of bacteria and bacterial products from the gut to the general circulation, preventing the chronic inflammation that takes place in cirrhotic patients.Recent investigations have shown that simvastatin, a drug which is widely used to treat high cholesterol levels for the prevention of cardiovascular diseases, may have beneficial effects in patients with cirrhosis by preventing the progression of the disease and its complications. Although in the past decades there was a concern about its use in patients with liver disease due to its rare adverse effects (liver and muscle toxicity), recent clinical trials have shown that it can be safely used in patients with cirrhosis.
The aim of this study is to evaluate the efficacy of oral administration of simvastatin plus rifaximin in halting the progression of decompensated cirrhosis as
assessed by the time to first incidence of ACLF during treatment period.REC name
London - Central Research Ethics Committee
REC reference
18/LO/1553
Date of REC Opinion
16 Nov 2018
REC opinion
Further Information Favourable Opinion