Future research direction of portal hypertension based on Baveno VII.
Xuefeng Luo, Guangchuan Wang, Li Yang...
https://pubmed.ncbi.nlm.nih.gov/40824526Actively Recruiting
Phase 2
Phase 3
Age: 18Years +
All Genders
ID04971577
Efficacy of Simvastatin in Reducing Liver Fibrosis in Patients With Advanced Fibrosis Due to Alcohol: Randomized, Double-blind, Placebo-controlled Clinical Trial
Led by Anna Cruceta · Updated on 2024-12-04
90
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of simvastatin in reducing liver fibrosis in patients who have advanced fibrosis caused by alcohol use. This study is a randomized, double-blind, placebo-controlled trial aimed at understanding whether simvastatin can improve liver condition in people with significant liver damage due to chronic alcohol-related liver disease. Participants will be randomly assigned to receive either simvastatin or a placebo. Those in the treatment group will take a capsule containing four tablets of simvastatin 10 mg (total 40 mg) every night. The study includes a treatment period of 18 months during which the effects on liver fibrosis will be carefully monitored and compared between groups. During the study, participants will undergo liver biopsies to measure changes in fibrosis using the Ishak fibrosis score. Other assessments will include monitoring for side effects, liver function, and overall health status. The primary outcome is the change in the histological fibrosis score from baseline after 18 months. Safety and compliance will be closely monitored throughout the study period, which may last up to nearly six years including follow-up.
CONDITIONS
Brief Title
Efficacy of Simvastatin in Alcoholic Liver Fibrosis
Who Can Participate
Age: 18Years +
All Genders
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 prior to randomization (Ishak fibrosis score 3 to 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 use of statins or fibrates
- Liver diseases other than alcohol-related, such as hepatitis B or C, autoimmune hepatitis, Wilson's disease, or hemochromatosis
- Hepatitis C cured with antivirals within 2 years before inclusion
- Creatine kinase elevation 50% above normal at inclusion
- Gastrointestinal bleeding from portal hypertension within 12 months prior to inclusion
- Grade II-IV hepatic encephalopathy within 12 months prior to inclusion
- Need for diuretic treatment for ascites or hydrothorax within past 12 months
- Spontaneous bacterial peritonitis within 12 months before enrollment
- Hepatocellular carcinoma of any stage
- Known muscle disease or previous rhabdomyolysis
- Treatment with strong CYP3A4 inhibitors or drugs interacting with simvastatin
- Significant extrahepatic disease with poor short-term prognosis
- Extrahepatic malignancies
- History or risk of intestinal obstruction
- Pregnancy or breastfeeding
- Participation in other clinical trials within previous month
- Mental disabilities, language barriers, poor social support, or other factors limiting study compliance
- Presence of alcoholic hepatitis in liver biopsy upon inclusion
- Contraindications or known hypersensitivity to simvastatin
- Refusal to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 18 months
Participants receive simvastatin or placebo daily to assess effects on liver fibrosis.
Regular visits during treatment as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Jordi Gratacos
Barcelona, Spain, 08036
Actively Recruiting
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Research Team
G
Gratacos
A
ana cruceta
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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