Actively Recruiting
Efficacy of Simvastatin in Alcoholic Liver Fibrosis
Led by Anna Cruceta · Updated on 2024-12-04
90
Participants Needed
1
Research Sites
301 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the efficacy of simvastatin in reducing liver fibrosis in patients with advanced fibrosis due to alcohol
CONDITIONS
Official Title
Efficacy of Simvastatin in Alcoholic Liver Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Chronic alcohol-related liver disease with significant liver fibrosis confirmed by biopsy within 6 months before randomization
- Significant liver fibrosis defined by Ishak fibrosis score between 3 and 6
- Compensated chronic liver disease phase without clinical decompensations at study entry
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study
You will not qualify if you...
- Current treatment with statins or fibrates
- Other liver diseases besides alcohol-related, including hepatitis C, hepatitis B, autoimmune hepatitis, Wilson's disease, or hemochromatosis
- Hepatitis C cured with antivirals within 2 years prior to study
- Creatine kinase elevation 50% or more above normal at study start
- Gastrointestinal bleeding due to portal hypertension within 12 months prior to study
- Clinical hepatic encephalopathy grade II-IV within 12 months prior to study
- Need for diuretics to control ascites or hydrothorax in previous 12 months
- Spontaneous bacterial peritonitis within 12 months prior to enrollment
- Hepatocellular carcinoma of any stage
- Known muscle disease or previous rhabdomyolysis
- Treatment with strong CYP3A4 enzyme inhibitors or drugs interacting with simvastatin
- Significant extrahepatic disease with poor short-term prognosis (e.g., severe heart failure, advanced COPD, chronic kidney disease with creatinine >2 mg/dL)
- Extrahepatic malignancies including solid and hematologic tumors
- History or risk of intestinal obstruction
- Pregnancy or breastfeeding
- Participation in other clinical trials within the previous month
- Mental disabilities, language barriers, poor social support, or other factors affecting study compliance
- Presence of alcoholic hepatitis on liver biopsy at inclusion
- Contraindications or hypersensitivity to statins or simvastatin
- Refusal to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jordi Gratacos
Barcelona, Spain, 08036
Actively Recruiting
Research Team
G
Gratacos
CONTACT
A
ana cruceta
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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