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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hospital Clinic De Barcelona	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	29.03.2022

Trial locations

Investigated drugs:

Simvastatin

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.

Investigated diseases:

Alcoholic liver disease

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.

Trial ID:

2024-519968-41-00

Protocol code:

SIMFIB

NCT ID:

NCT04971577

Trial Phase:

Therapeutic use (Phase IV)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?