Clinical trials on cirrhosis of the liver

Cirrhosis of the Liver: An Overview

Cirrhosis of the liver is a late stage of scarring (fibrosis) of the liver caused by many forms of liver diseases and conditions, such as hepatitis and chronic alcoholism. Each time your liver is injured, it tries to repair itself. In the process, scar tissue forms. As the cirrhosis progresses, more and more scar tissue forms, making it difficult for the liver to function (decompensated cirrhosis). The liver damage done by cirrhosis generally can’t be undone, but if liver cirrhosis is diagnosed early and the cause is treated, further damage can be limited and, rarely, reversed.

Causes and Symptoms

The causes of cirrhosis are multifaceted, ranging from chronic alcohol abuse and hepatitis B and C infections to fatty liver disease and genetic disorders. Early stages of cirrhosis often produce no symptoms. However, as the liver function deteriorates, symptoms may include fatigue, easy bruising, jaundice (yellowing of the skin and eyes), itchy skin, fluid accumulation in the abdomen (ascites), and weight loss.

Diagnosis and Treatment

Diagnosing cirrhosis involves a combination of history taking, physical examination, blood tests, imaging tests (such as MRI, CT scan, and ultrasound), and sometimes a liver biopsy. Treatment focuses on slowing the progression of the scar tissue in the liver and managing the symptoms and complications. This may involve lifestyle changes, medication, or in advanced cases, a liver transplant. It’s crucial for individuals with cirrhosis to avoid alcohol and any other substances that can further damage the liver.

Prognosis for Cirrhosis of the Liver

Cirrhosis of the liver is a condition characterized by the replacement of healthy liver tissue with scar tissue, which impedes the organ’s proper functioning. The long-term prospects associated with cirrhosis vary widely, influenced by the stage of the disease at diagnosis and the underlying cause. In its early stages, the progression of cirrhosis can be slow, allowing for a potentially extended duration of life with the disease. However, as the condition advances, the incidence of complications increases, and liver function significantly deteriorates, potentially leading to liver failure. A more favorable prognosis is associated with early detection of the disease and prevention of further liver damage. For advanced stages, the prognosis becomes less optimistic, and the condition may necessitate a liver transplant. Overall life expectancy for individuals with cirrhosis is highly individualized, influenced by various factors, including overall health, lifestyle choices, and adherence to medical advice.

Complications in Cirrhosis of the Liver

Cirrhosis of the liver can lead to various complications that significantly impact health and daily living. Common issues include:

  • Fluid buildup in the abdomen, known as ascites, which can cause discomfort and breathing difficulties.
  • The liver’s inability to filter toxins properly may result in confusion, memory problems, or changes in behavior, a condition known as hepatic encephalopathy.
  • Bleeding from enlarged veins in the esophagus or stomach, which can be life-threatening.
  • Cirrhosis can weaken the immune system, increasing susceptibility to infections.
  • The compromised function of the liver can also lead to jaundice, where the skin and eyes turn yellow, and it can affect the body’s ability to process nutrients, leading to weight loss and muscle wasting.

These complications can severely diminish quality of life, causing both physical discomfort and emotional distress.

Treatment Methods for Liver Cirrhosis

For the management of liver cirrhosis, lifestyle modifications are crucial. A balanced diet low in sodium and rich in fruits, vegetables, and lean proteins supports liver health. The avoidance of alcohol is essential as it can exacerbate liver damage. Regular physical activity helps in maintaining a healthy weight, reducing liver strain.

Pharmacotherapy may include medications to manage symptoms and complications. Diuretics are often prescribed to reduce fluid buildup, and laxatives may be utilized to eliminate toxins from the body. Beta-blockers can lower blood pressure in the veins around the liver, preventing bleeding.

Modern technology offers non-invasive tools for monitoring liver health. FibroScan, for example, utilizes ultrasound waves to assess liver stiffness and fat accumulation without the need for a biopsy. Wearable technology can track vital signs and encourage adherence to medication schedules.

The incorporation of these methods can contribute to better management of liver cirrhosis, improving the quality of life.

  • CT-EU-00029691

    Study on Zibotentan-Dapagliflozin Combo for Cirrhosis Patients

    The ZEAL study is a study conducted in people suffering from cirrhosis, a disease that causes the accumulation of scar tissue in the liver. The study was divided into two parts and aims to determine how helpful and safe a combination of drugs called zibotentan and dapagliflozin is when given to people suffering from this disease. In the first part, drugs will be administered to one group of volunteers and their reaction will be observed. If no significant safety issues arise, the study will proceed to the second part. Here, more people with varying degrees of liver disease will participate. Several things will be checked: improvement in blood pressure in the liver, effect on body weight, use of other medications to store fluid, and changes in body water and fat content.

    • dapagliflozin
    • zibotentan
  • Testing new medicine for liver cirrhosis with high blood pressure

    This research project focuses on examining a new drug – BI 685509 alone or alongside another drug called empagliflozin. The study wants to find out if these drugs can assist people suffering from cirrhosis of the liver. Cirrhosis is a disease where for liver it gets hard to function properly. It can be caused by viruses like hepatitis B and C or by a condition known as non-alcoholic steatohepatitis (NASH), which is related to fat build-up in the liver. These patients also have high blood pressure in the portal vein, a large vessel that carries blood to the liver. During the study, which lasts for about three months, the patient will have to take BI 685509 tablets two times daily for eight weeks. If the patient has diabetes as well, they will also have to consume empagliflozin once a day. The patient will be required to visit the study site around 10 times, with the occasional use of a slender tube, known as a catheter, to assess the pressure in the liver vein.

    • BI 685509- new potential medication for chronic kidney disease (CKD), portal hypertension, cirrhosis, and diabetic nephropathy
    • Empagliflozin
  • Exploring a novel treatment for liver fibrosis and cirrhosis

    This clinical trial is testing a new drug called ALE.F02 for patients with advanced fibrosis or cirrhosis of the liver. The test will observe how the body deals with the drug. Some patients will receive ALE.F02 and some will receive a placebo (a medicine without active substances) for comparison. Scientists will measure the highest level of the drug in the blood, when that level is reached, and the total amount of the drug in the body over time. They will also look at changes in certain proteins in the blood (CD44, PRO-C3, TIMP1, hyaluronic acid and PIIINP) before and after the treatment. They will track any side effects or serious problems that occur during the study, using common terminology criteria for adverse events (a standardized measure of side effects).

    • lixudebart/ALE.F02
  • Effectiveness of setanaxib in primary biliary cholangitis

    This clinical trial aims to study the effectiveness of a new medication called setanaxib on patients suffering from primary biliary cholangitis (PBC), a type of liver disorder, and with elevated liver stiffness. The drug is being tested for its ability to improve patients’ health over a course of a year. Participants of the study, adults aged 18 years and older, are either not responding adequately or are intolerant to a common PBC treatment, Ursodeoxycholic acid (UDCA). The study employs a randomized double-blind method, meaning patients are randomly placed into groups and neither patients nor researchers know who gets the actual drug or a placebo. The trial will last 52 weeks with an extension phase that could last an additional year. 

    • Setanaxib