Efficacy of the combination of simvastatin plus rifaximin in patients with decompensated cirrhosis

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 240

Inclusion Criteria

1. Age = 18 years old.
2. Cirrhosis defined by standard clinical criteria, ultrasonographic
findings and/or histology. Cirrhosis of any aetiology may be included.
However, patients with cirrhosis due to autoimmune hepatitis must be
on stable corticosteroid dose for =3-month period before study
inclusion.
3. Child-Pugh B patients or Child-Pugh C patients (up to 12 points).
4. Women of child-bearing potential* must have a negative pregnancy
test in serum normal at study inclusion.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

1. Patients on treatment with statins or rifaximin up to one month
before study inclusion.
2. Patients with contraindications for statins or rifaximin therapy.
3. Known hypersensitivity to simvastatin or rifaximin (or rifamycin
derivatives).
4. Patients with CK elevation of 50% or more above the upper limit of
5. Patients on treatment with potent inhibitors of CYP3A4 enzyme (See
section 5.2: Concomitant, nonpermitted and permitted medication).
6. Patients on treatment with drugs with potential interactions with
simvastatin (see section 5.2: Concomitant, nonpermitted and
permitted medication).
7. Patients with previous history of myopathy.
8. Patients with previous history of intestinal obstruction or those who
are at increased risk of this complication.
9. Patients with ACLF according to the criteria published by Moreau et
al. (see appendix 2).
10. Serum creatinine =2 mg/dL (176.8 µmol/L).
11. Serum bilirubin>5 mg/dL (85.5 µmol/L).
12. INR =2.5.
13. Bacterial infection within 10 days before study inclusion.
14. Gastrointestinal bleeding within 10 days before study inclusion.
15. Current overt hepatic encephalopathy, defined as grade II-IV
hepatic encephalopathy according to the New-Haven classification.
16. Patients with active hepatocellular carcinoma or history of
hepatocellular carcinoma that is in remission for less than six months
for uninodular HCC or for less than 12 months for multinodular HCC
within Milan criteria.
17. Patients on antiviral therapy for HCV or those who have received it
within the last 6 months.
18. Severe alcoholic hepatitis requiring corticosteroid therapy
(Maddrey’s Discriminant function = 32 and/or ABIC score > 6.7).
19. Patients with active alcohol consumption of more than 21 units per
week.
20. HIV infection.
21. Patients with a history of significant extra hepatic disease with
impaired short-term prognosis, including congestive heart failure New
York Heart Association Grade III/IV, COPD GOLD >2, chronic kidney
disease with serum creatinine >2mg/dL or under renal replacement
therapy.
22. Patients with current extra hepatic malignancies including solid
tumours and hematologic disorders.
23. Pregnancy or breastfeeding.
24. Patients included in other clinical trials in the month before
inclusion.
25. Patients with mental incapacity, language barrier, bad social
support or any other reason considered by the investigator precluding
adequate understanding, cooperation or compliance in the study.
26. Refusal to give informed consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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