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Study on Simvastatin for Treating Primary Sclerosing Cholangitis in Patients

Fast replyRegistered drugNo placebo

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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 a liver disease called Primary Sclerosing Cholangitis (PSC). PSC is a condition that affects the bile ducts, which are tubes that carry bile from the liver to the small intestine. The study will use Simvastatin Sandoz 40 mg film-coated tablets as the treatment, and some participants will receive a placebo for comparison.

The purpose of the study is to determine if treatment with simvastatin can help prolong the time patients live without developing bile duct cancer, experiencing bleeding from enlarged veins in the esophagus (variceal bleeding), or needing a liver transplant. Participants in the study will be randomly assigned to receive either simvastatin or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study.

The study will take place over a period of time, during which participants will be monitored for various health outcomes. These include the number of days from the start of the study to events such as death, the need for a liver transplant, or the first occurrence of variceal bleeding. Additionally, the study will track changes in certain blood tests and symptoms related to PSC, such as itching or infections that require treatment. The study aims to provide valuable information on whether simvastatin can be an effective treatment for PSC.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization
Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the medication simvastatin, and the other group will receive a placebo. A placebo is a substance with no active medication, used to compare effects.
Step 2
Medication administration
If assigned to the simvastatin group, you will take a 40 mg film-coated tablet of Simvastatin Sandoz orally each day. If assigned to the placebo group, you will take a placebo tablet that looks like the simvastatin tablet but contains no active medication.
Step 3
Monitoring and assessments
Throughout the study, your health will be monitored regularly. This includes checking serum concentrations of substances like alkaline phosphatase and bilirubin, which are indicators of liver function.
Your MELD Score and Child Pugh Score will be assessed. These scores help evaluate the severity of liver disease.
You will undergo imaging tests such as MR (magnetic resonance) to monitor the progress of your condition.
Symptoms related to primary sclerosing cholangitis (PSC), such as itching or bacterial infections requiring treatment, will be recorded.
Step 4
Endpoints evaluation
The study will track the number of days from randomization to various events, such as death, liver transplantation listing, first variceal bleeding, or diagnosis of bile duct cancer.
Secondary outcomes include changes in liver function tests, imaging results, and the development of related conditions like colon cancer.
Step 5
Study duration
The study is expected to continue until September 30, 2030. Your participation will involve regular follow-ups and assessments throughout this period.

Who can join the trial?

6 criteria

Patients must have a confirmed diagnosis of Primary Sclerosing Cholangitis (PSC), which is a liver disease, through specific tests like a cholangiogram or liver biopsy. This can include patients with or without Inflammatory Bowel Disease (IBD), a condition affecting the digestive tract.
Both men and women can participate if they are at least 18 years old but not older than 75 years.
Patients must provide written consent, meaning they agree in writing to take part in the study.
Patients need to have had an MR/MRCP scan, which are types of imaging tests, within the last 4 months.
If the patient has a known IBD, they must have had a colonoscopy, a test to check the inside of the colon, within the last 24 months.
Women who can have children must agree to use a highly effective method of birth control while participating in the study.

Who cannot join the trial?

8 criteria

Patients who have a different liver condition other than Primary Sclerosing Cholangitis (PSC) cannot participate. PSC is a disease that affects the bile ducts in the liver.
Patients who are younger than 18 years old or older than 65 years old are not eligible.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have had a liver transplant are excluded from participating.
Patients who have a history of bile duct cancer cannot join the study.
Patients who have experienced variceal bleeding, which is bleeding from enlarged veins in the esophagus or stomach, are not eligible.
Patients who are unable to give informed consent, meaning they cannot understand the study and agree to participate, are excluded.
Patients who are currently participating in another clinical trial are not allowed to join this study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Danderyds Sjukhus AB
Danderyd, Sweden
Verified
Karolinska University Hospital
Solna, Sweden
Responsive
Region Vaesterbotten
Umea, Sweden

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Investigated drugs

Simvastatin is a medication used in this clinical trial to see if it can help people with primary sclerosing cholangitis (PSC). The study is looking at whether taking simvastatin can help patients live longer without developing bile duct cancer, experiencing variceal bleeding, or needing a liver transplant. Simvastatin is commonly used to lower cholesterol, but in this trial, researchers are exploring its potential benefits for PSC patients.

Simvastatin

What is already known about the treatment

Simvastatin – Simvastatin is typically administered orally in tablet form. It is currently being studied in clinical trials for its potential benefits in treating primary sclerosing cholangitis (PSC), a liver disease. The main therapeutic indication being explored is whether simvastatin can prolong survival free from bile duct cancer, variceal bleeding, and the need for liver transplantation in PSC patients. At the molecular level, simvastatin works by inhibiting an enzyme called HMG-CoA reductase, which plays a crucial role in cholesterol production in the liver. It is classified pharmacologically as a statin, a type of medication primarily used to lower cholesterol levels.

Investigated diseases

Primary sclerosing cholangitis – This is a chronic liver disease characterized by inflammation and scarring of the bile ducts, which can lead to liver damage over time. The bile ducts become narrowed and blocked, causing bile to accumulate in the liver, potentially leading to liver cirrhosis. Symptoms may include fatigue, itching, and jaundice, although some individuals may not experience noticeable symptoms initially. As the disease progresses, complications such as infections, vitamin deficiencies, and liver failure can occur. The exact cause of primary sclerosing cholangitis is not well understood, but it is often associated with inflammatory bowel diseases like ulcerative colitis. The progression of the disease varies among individuals, with some experiencing a slow progression and others facing more rapid liver damage.