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Study on Simvastatin for Reducing Liver Fibrosis in Patients with Advanced Alcohol-Related Liver Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication simvastatin on patients with advanced liver damage caused by alcohol, known as alcoholic liver disease. The trial aims to determine if simvastatin can help reduce the scarring of the liver, referred to as liver fibrosis. Simvastatin is a medication commonly used to lower cholesterol, and in this study, it will be compared to a placebo to see if it can improve liver health in affected individuals.

The purpose of the study is to see if simvastatin can significantly reduce liver fibrosis in patients with chronic liver disease due to alcohol. Participants will receive either simvastatin or a placebo and will be monitored over a period of 24 months. During this time, the health of their liver will be assessed through various methods, including liver biopsies, which involve taking a small sample of liver tissue to examine under a microscope. The study will also look at changes in liver stiffness, which can be measured using special imaging techniques, and other markers in the blood that indicate liver health.

Throughout the study, researchers will also explore other aspects of liver health, such as changes in the gut microbiome, which is the community of bacteria living in the intestines, and markers of inflammation in the body. The safety and any side effects of simvastatin will be closely monitored to ensure the well-being of participants. This trial is designed to provide valuable insights into whether simvastatin can be a beneficial treatment for reducing liver damage in patients with alcoholic liver disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a diagnostic liver biopsy if not done within the last 6 months.
Women of childbearing potential must take a urine pregnancy test and agree to use effective contraceptive methods during the study.
Step 2
Randomization
Participants are randomly assigned to one of two groups: one receiving the active medication, simvastatin, and the other receiving a placebo. This process is double-blind, meaning neither the participants nor the researchers know which group each participant is in.
Step 3
Medication administration
If assigned to the simvastatin group, take one 40 mg film-coated tablet orally each day. If assigned to the placebo group, take one placebo tablet daily. This continues for the duration of the study.
Step 4
Regular follow-up visits
Attend regular follow-up visits at 6, 12, 18, and 24 months. These visits include assessments of liver elasticity using noninvasive methods and blood tests to measure various markers related to liver health and inflammation.
Step 5
Final assessment
At the end of 24 months, a final liver biopsy is performed to evaluate changes in liver fibrosis. Additional tests may be conducted to assess other health parameters.
Step 6
Study completion
Upon completion of the study, participants are informed about the group they were in and receive information about the overall study results.

Who can join the trial?

4 criteria

Must be 18 years or older.
Have a chronic liver disease related to alcohol, as defined by international guidelines. Must have evidence of significant liver damage (fibrosis) from a liver biopsy done at the start of the study or within the last 6 months. Significant liver damage is defined by a score between 3 and 6 on the Ishak fibrosis scale, which measures the extent of liver scarring.
Be in the compensated phase of chronic liver disease, meaning the liver is still functioning well without major symptoms, with or without signs of increased blood pressure in the liver (portal hypertension).
Women who can have children must have a negative pregnancy test before joining the study and agree to use highly effective birth control methods, such as the pill, injections, implants, or an intrauterine device (IUD), during the study.

Who cannot join the trial?

11 criteria

Patients with any other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent history of alcohol or drug abuse.
Patients who are currently participating in another clinical trial.
Patients with known allergies to the study medication or similar drugs.
Patients with severe kidney disease.
Patients with a history of cancer within the last five years, except for certain skin cancers.
Patients with uncontrolled diabetes or high blood pressure.
Patients who have had a liver transplant.
Patients with HIV or Hepatitis B/C infections.
Patients who are unable to comply with the study procedures.

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Hospital Clinic De Barcelona
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Barcelona, Spain

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Investigated drugs

Simvastatin is a medication that is being tested in this clinical trial to see if it can help reduce liver fibrosis in patients who have advanced liver damage due to alcohol use. Liver fibrosis is a condition where the liver becomes scarred and doesn't work as well as it should. Simvastatin is usually used to lower cholesterol, but researchers are exploring if it can also help improve liver health by reducing the amount of scarring in the liver. In this trial, patients will receive simvastatin to see if it can make a significant difference in their liver condition compared to those who do not receive the medication.

Simvastatin

What is already known about the treatment

Simvastatin – Simvastatin is taken orally in the form of a tablet. It is currently being studied for its potential to reduce liver fibrosis in patients with advanced liver damage due to alcohol consumption. The main therapeutic use being investigated is its ability to decrease the severity of liver fibrosis, which is a type of scarring in the liver. At the molecular level, simvastatin works by inhibiting an enzyme involved in cholesterol production, which may also have effects on liver cells and reduce fibrosis. It is classified as a statin, a type of medication primarily used to lower cholesterol levels in the blood.

Investigated diseases

Chronic Liver Disease
Chronic liver disease refers to a range of liver conditions that cause long-term damage to the liver. Over time, this damage can lead to scarring, known as fibrosis, which can progress to cirrhosis. As the disease progresses, the liver's ability to function properly diminishes, affecting its role in detoxifying the blood, producing proteins, and storing energy. Symptoms may not be apparent in the early stages but can include fatigue, jaundice, and abdominal swelling as the disease advances. The progression of chronic liver disease can vary depending on the underlying cause and individual factors. It is important to monitor liver function and fibrosis progression to manage the disease effectively.
Alcoholic Liver Disease
Alcoholic liver disease is a condition caused by excessive alcohol consumption, leading to liver damage. It progresses through stages, starting with fatty liver, where fat accumulates in liver cells. If alcohol consumption continues, it can lead to alcoholic hepatitis, characterized by inflammation and liver cell damage. Over time, this can progress to fibrosis and eventually cirrhosis, where extensive scarring impairs liver function. Symptoms may include jaundice, abdominal pain, and swelling, but they often become noticeable only in advanced stages. The progression of alcoholic liver disease depends on the amount and duration of alcohol consumption, as well as individual susceptibility.