NCT03780673

Efficacy of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosis to Prevent ACLF Development

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: Judit Pich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the efficacy of oral administration of simvastatin plus rifaximin in patients with decompensated cirrhosis to halt the progression of the disease as assessed by prevention of the development of ACLF

Detailed description

The current study was aimed at assessing whether a treatment based on combination of rifaximin and simvastatin would be effective in patients with decompensated cirrhosis to prevent ACLF development Considering that statins have been scarcely investigated in patients with decompensated cirrhosis due to a concern of potential higher liver and muscle toxicity in this population, a first LIVERHOPE\_SAFETY clinical trial (unpublished) was undergone to assess safety and toxicity of statins with decompensated cirrhosis. As a preliminary result of the LIVERHOPE\_SAFETY clinical trial, it was concluded that the dose of Simvastatin 20mg per day plus Rifaximin is not associated to a higher risk of liver or muscle toxicity in patients with decompensated cirrhosis and simvastatin 20 mg was established for the LIVERHOPE\_EFFICACY study.

Conditions

• Liver Cirrhoses

Interventions

Type	Name	Description
DRUG	Simvastatin	Simvastatin 20 mg/day for 12 months
DRUG	Rifaximin	Rifaximin 400/8 hours for 12 months
DRUG	Placebo of Simvastatin	Placebo of Simvastatin once a day for 12 months
DRUG	Placebo of Rifaximin	Placebo of Rifaximin/8 hours for 12 months

Timeline

• Start date: 2019-01-03
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2018-12-19
• Last updated: 2023-05-24

Locations

14 sites across 7 countries: Belgium, France, Germany, Italy, Netherlands, Spain, United Kingdom