Rare diseases
Investigational molecules
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Recruiting trials first
4 clinical trials in this condition
Spain
Denmark
BulgariaBulgariaIn short
Currently, there are 3 clinical trials investigating new treatments for alcoholic liver disease, taking place across several European countries. These trials are testing different approaches to reduce liver damage and improve liver function in patients affected by excessive alcohol consumption.
This trial compares two forms of a medication called Essentiale, which contains phosphatidylcholine derived from soya beans. The study is examining whether the liquid form works as well as the capsule form when added to standard treatment for liver conditions.
Who can participate: Adults between 18 and 70 years old who have been diagnosed with fatty liver disease related to metabolic problems, liver disease caused by alcohol, or long-term hepatitis B infection. Participants must have symptoms such as energy loss, feeling depressed, stomach pain, tiredness, trouble sleeping, loss of appetite, or nausea, scoring 3 or higher on an assessment scale. They must be receiving standard medical care for their liver condition and agree to stop drinking alcohol and participate in alcohol treatment if they have a history of alcoholism. Women who can become pregnant must use effective birth control during the study and for 30 days after. Men with partners who can become pregnant must use condoms along with their partner's contraception.
Who cannot participate: People under 18 or over 65 years old, those with severe liver disease, individuals with known allergies to the study medication, pregnant or breastfeeding women, people participating in other clinical trials, individuals with autoimmune diseases, uncontrolled diabetes, serious heart conditions, severe kidney problems, those who had major surgery within the last 3 months, individuals with active cancer or undergoing cancer treatment, and people with a history of drug or alcohol abuse within the past 6 months.
What the trial involves: Participants will be randomly assigned to receive either Essentiale liquid (1800 mg once daily) with placebo capsules, or Essentiale capsules (300 mg) with placebo liquid. Treatment continues for 87 days while maintaining standard care for liver disease. Regular evaluations assess symptoms using a Global Overall Symptom score, which includes energy loss, depression, abdominal pain, fatigue, sleeping problems, appetite loss, and nausea. Quality of life is also assessed using a specific questionnaire. Safety monitoring occurs throughout the study to record any side effects or new health issues.
The investigational drug, Essentiale, contains essential phospholipids that help protect and repair liver cells. The medication works by incorporating phospholipids into damaged liver cell membranes, helping to restore liver cell function and promote liver regeneration.
Three clinical trials are currently recruiting patients with alcoholic liver disease across Europe. The trials are notably concentrated in Germany and Spain, with Germany hosting two of the three studies. Each trial takes a different therapeutic approach: one tests a novel injectable medication (GSK4532990) targeting liver inflammation pathways, another compares different formulations of a phospholipid-based liver protectant (Essentiale), and the third repurposes a cholesterol-lowering medication (simvastatin) to address liver scarring.
The trials vary significantly in their duration and scope. The GSK4532990 study involves a single injection followed by monitoring, while the Essentiale trial runs for 87 days, and the simvastatin study extends over 24 months. The longest study also requires the most invasive procedures, including liver biopsies at the beginning and end of treatment.
All three trials emphasize the importance of abstinence from alcohol and require participants to engage with alcohol withdrawal programs where applicable. Female participants of childbearing age across all studies must use effective contraception, reflecting the potential risks these medications may pose during pregnancy. The studies collectively represent different stages of liver disease severity, from compensated liver disease to advanced cirrhosis, offering potential treatment options for patients at various points in disease progression.
This guide is here to help you understand the condition. It does not replace a conversation with your doctor, who knows your situation best.
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