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Simvastatin Plus Rifaximin in Decompensated Cirrhosis

NCT03150459 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-03-28

No results posted yet for this study

Summary

The main purpose of this study is to investigate whether the combination of two different drugs, simvastatin and rifaximin, is safe in the treatment of patients with decompensated cirrhosis.

The secondary purpose is to see if this combination results in an improvement in inflammation markers in patients with cirrhosis and in an improvement in analytic parameters of progression of liver disease.

Conditions

  • Cirrhoses, Liver

Interventions

DRUG

Simvastatin 20 mg

Simvastatin 20 mg/day for 12 weeks (Group 1)

DRUG

Simvastatin 40mg

Simvastatin 40 mg/day for 12 weeks (Group 2)

DRUG

Rifaximin 400 mg

Rifaximin 400 mg/8 hours for 12 weeks (Group 1 and 2)

OTHER

Placebo of Simvastatin

Placebo of Simvastatin for 12 weeks (Group 3)

OTHER

Placebo of Rifaximin

Placebo of Rifaximin for 12 weeks (Group 3)

Sponsors & Collaborators

  • Judit Pich

    lead OTHER

Principal Investigators

  • Pere Ginès, MD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-26
Primary Completion
2018-03-12
Completion
2018-03-12

Countries

  • 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 NCT03150459 on ClinicalTrials.gov