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

NCT03780673 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2023-05-24

No results posted yet for this study

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

Conditions

  • Liver Cirrhoses

Interventions

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

Sponsors & Collaborators

  • Judit Pich

    lead OTHER

Principal Investigators

  • Pere Ginès, MD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-03
Primary Completion
2022-12-01
Completion
2022-12-01

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03780673 on ClinicalTrials.gov