Efficacy of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosi⦠(NCT03780673) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosis to Prevent ACLF Development
Belgium, France, Germany254 participantsStarted 2019-01-03
Plain-language 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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ā„ 18 years old
* Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology
* Child-Pugh patients or Child-Pugh C patients (up to 12 points)
* Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence.
Exclusion Criteria:
* Patients on treatment with statins or rifaximin up to one month before study inclusion.
* Patients with contraindications for statins or rifaximin therapy.
* Known hypersensitivity to simvastatin or rifaximin (or rifamycin derivatives).
* Patients with CK elevation of 50% or more above the upper limit of normal at study inclusion.
* Patients on treatment with potent inhibitors of CYP3A4 enzyme
* Patients on treatment with drugs with potential interactions with simvastatin
* Patients with previous history of myopathy.
* Patients with previous history of intestinal obstruction or those who are at increased risk of this complication.
* Patients with ACLF according to the criteria published by Moreau et al.
* Serum creatinine ā„2 mg/dL (176.8 μmol/L).
* Serum bilirubin\>5 mg/dL (85.5 μmol/L).
* 12\. INR ā„2.5
* Bacterial infection within 10 days before study inclusion.
* Gastrointestinal bleeding within 10 days before study inclusion.ā¦