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Tests treatment safety and results for Liver Fibrosis
Official title Efficacy of Simvastatin in Alcoholic Liver Fibrosis
ClinicalTrials.gov ID: NCT04971577
What this study is testing
What is Simvastatin 40mg?
Simvastatin 40mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for liver fibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Evaluate the efficacy of simvastatin in reducing liver fibrosis in patients with advanced fibrosis due to alcohol
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Chronic alcohol-related liver disease according to international guidelines (EASL, European Association for the Study of the Liver) and with data of...
- Patients in the compensated chronic liver disease phase defined by the absence of clinical decompensations at the time of entering the study, with or...
- Women of childbearing potential must have a negative urine pregnancy test prior to study enrollment and agree to use highly effective contraceptive...
You likely can't join if
- Patients receiving statins or fibrates.
- Patients with other etiologies of liver disease in addition to alcohol: hepatitis C, hepatitis B, autoimmune hepatitis, Wilson's disease, or...
- Patients in whom hepatitis C has been cured with antivirals in the 2 years prior to inclusion in the study.
- Patients with a CK elevation of 50% or more above the upper limit of normal at the time of study inclusion.
- Gastrointestinal bleeding due to portal hypertension within 12 months prior to inclusion in the study.
- Clinical hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy, in the 12 months prior to inclusion in the study.
See the full eligibility criteria
- Age ≥ 18 years
- Chronic alcohol-related liver disease according to international guidelines (EASL, European Association for the Study of the Liver) and with data of significant liver fibrosis obtained in the diagnostic biopsy at the...
- Patients in the compensated chronic liver disease phase defined by the absence of clinical decompensations at the time of entering the study, with or without data of portal hypertension.
- Women of childbearing potential must have a negative urine pregnancy test prior to study enrollment and agree to use highly effective contraceptive methods (combined oral pill, injectable or implanted contraceptive...
- Patients receiving statins or fibrates.
- Patients with other etiologies of liver disease in addition to alcohol: hepatitis C, hepatitis B, autoimmune hepatitis, Wilson's disease, or hemochromatosis.
- Patients in whom hepatitis C has been cured with antivirals in the 2 years prior to inclusion in the study.
- Patients with a CK elevation of 50% or more above the upper limit of normal at the time of study inclusion.
- Gastrointestinal bleeding due to portal hypertension within 12 months prior to inclusion in the study.
- Clinical hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy, in the 12 months prior to inclusion in the study.
- Patients in need of diuretic treatment in the previous 12 months to control ascites or hydrothorax.
- Spontaneous bacterial peritonitis within 12 months prior to study enrollment.
- Hepatocellular carcinoma of any stage.
- Patients with known muscle disease.
- Patients with previous rhabdomyolysis.
- Patients being treated with strong CYP3A4 enzyme inhibitors (see section 5.2: Concomitant drugs, not allowed and allowed).
- Patients being treated with drugs with possible interactions with simvastatin (see section 5.2: Concomitant drugs, not allowed and allowed).
- Patients with a history of significant extrahepatic disease with poor short-term prognosis, including New York Heart Association Grade III / V congestive heart failure, GOLD COPD\> 2, chronic kidney disease with serum...
- Patients with extrahepatic malignancies, including solid tumors and hematologic malignancies.
- Patients with a history or increased risk of intestinal obstruction.
- Pregnancy or breastfeeding.
- Patients included in other clinical trials during the previous month.
- Patients with mental disabilities, language barriers, poor social support or any other reason considered by the researcher as essential for adequate understanding, cooperation or compliance with the study.
- Presence of data on alcoholic hepatitis in liver biopsy upon inclusion.
- Patients with contraindications for statins.
- Known hypersensitivity to simvastatin.
- Refusal to sign the informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.