Ongoing Clinical Trials for Alcoholic Cirrhosis
Currently, there are 2 ongoing clinical trials investigating new treatment approaches for alcoholic cirrhosis. These studies are testing medications that may help prevent disease progression and complications in patients with different stages of liver cirrhosis. Trials are being conducted in France and Italy, focusing on medications that target blood pressure in the liver and fluid management.
Clinical trial locations
- France
- Italy
Study on Carvedilol for Preventing Complications in Patients with Early-Stage Cirrhosis and High Blood Pressure in the Liver
This trial is investigating whether carvedilol can help prevent the worsening of cirrhosis or liver-related death in patients with early-stage disease. The study specifically targets patients who have cirrhosis that is not yet causing symptoms but who have increased blood pressure in the portal vein, which carries blood from the digestive organs to the liver.
Main inclusion criteria: Patients must be at least 18 years old with cirrhosis caused by hepatitis C or B (inactive for at least 2 years), alcohol use, or metabolic syndrome. The liver stiffness must measure 25 kPa or higher on Fibroscan testing. Patients should have a Child-Pugh score between A5 and B8, indicating early to moderate liver disease. An endoscopy must confirm that there are no medium or large varices or small varices with red signs. Women of childbearing age must use contraception.
Main exclusion criteria: Patients cannot have symptoms of cirrhosis or a Child-Pugh class higher than B8. Those with liver stiffness below 25 kPa or high-risk varices are not eligible. Vulnerable populations are also excluded from participation.
Study focus: The trial will monitor participants for 36 months to see if taking carvedilol at a low dose (up to 12.5 mg per day) can prevent cirrhosis complications or liver-related death. The study is double-blind, meaning neither participants nor researchers will know who receives the actual medication versus placebo. Regular monitoring will assess heart rate, blood pressure, and cardiac function to evaluate safety. Researchers will also look for predictors of treatment response, such as changes in liver and spleen stiffness.
Investigational drug: Carvedilol is a non-selective beta-blocker with additional alpha-blocking activity. It works by blocking certain receptors in the heart and blood vessels, helping to lower blood pressure and reduce the workload on the heart. The medication is taken orally in tablet form.
Study on Dapagliflozin for Patients with Decompensated Liver Cirrhosis
This clinical trial is evaluating the safety of dapagliflozin in patients with decompensated liver cirrhosis, a more advanced stage where the liver is no longer able to function properly and serious health complications occur.
Main inclusion criteria: Patients must be between 18 and 85 years old with a confirmed diagnosis of liver cirrhosis through tissue examination or imaging tests such as ultrasound, CT scan, or liver elastography showing stiffness greater than 15 kPa. Importantly, patients must have experienced liver decompensation within the past 12 months, meaning they have had serious symptoms such as confusion due to liver failure, significant fluid buildup in the abdomen, or bleeding from swollen veins in the esophagus.
Main exclusion criteria: Patients with decompensated liver cirrhosis are generally excluded from many studies, but this trial specifically focuses on this population to evaluate the medication’s safety in advanced disease.
Study focus: The primary goal is to evaluate the safety of dapagliflozin compared to standard medical treatments over several months. Researchers will monitor participants for side effects and track the occurrence of specific complications such as variceal bleeding, hepatic encephalopathy, fluid buildup in the abdomen, hepatorenal syndrome, and spontaneous bacterial peritonitis. Health assessments will be conducted at regular intervals: days 28, 56, 84, 112, 140, and 168. The study will also measure changes in various health scores and biomarkers to understand the medication’s impact on liver function and overall health. The trial is expected to conclude by May 2026.
Investigational drug: Dapagliflozin (marketed as Forxiga) is an SGLT2 inhibitor originally used to manage blood sugar levels in type 2 diabetes. It works by inhibiting a protein in the kidneys that reduces glucose reabsorption and increases glucose excretion in urine. In this trial, the 10 mg film-coated tablets are being studied for their potential safety and benefits in patients with advanced liver disease.
Summary
These two ongoing clinical trials represent different approaches to managing cirrhosis at various stages of disease progression. The French trial focuses on early intervention with carvedilol in patients with asymptomatic cirrhosis and portal hypertension, aiming to prevent disease progression over three years. In contrast, the Italian study evaluates dapagliflozin in patients who already have decompensated cirrhosis with serious complications, focusing primarily on safety.
The trials test medications from different drug classes: carvedilol is a beta-blocker that lowers blood pressure in the liver’s portal system, while dapagliflozin is an SGLT2 inhibitor originally developed for diabetes that may help manage fluid complications. Both studies employ rigorous monitoring protocols to assess not only effectiveness but also safety, which is particularly important in patients with compromised liver function. These trials may provide important insights into new treatment options for patients at different stages of cirrhosis progression.
