Ongoing Clinical Trials for Esophageal Varices
There is currently 1 ongoing clinical trial investigating new treatments for esophageal varices in patients with liver cirrhosis. This trial is testing an investigational medication called Belapectin to see if it can help prevent the development of these enlarged veins in the esophagus, which can lead to serious bleeding complications. The study is taking place across multiple European countries and is open to adults with NASH cirrhosis who do not yet have esophageal varices.
Clinical trial locations
- Belgium
- France
- Germany
- Poland
- Spain
Study on Belapectin for Preventing Esophageal Varices in Patients with NASH Cirrhosis
This clinical trial is investigating whether a medication called Belapectin (also known as GR-MD-02) can help prevent the development of esophageal varices in people who have NASH cirrhosis. NASH stands for Non-Alcoholic Steatohepatitis, a type of liver disease caused by fat buildup and inflammation that leads to liver scarring. Esophageal varices are enlarged, swollen veins in the esophagus that can develop when liver disease causes increased pressure in the blood vessels. These varices are dangerous because they can burst and cause serious, life-threatening bleeding.
Main goal of the trial: The primary purpose of this study is to evaluate whether Belapectin can effectively prevent the formation of esophageal varices in patients with NASH cirrhosis over an 18-month period. Researchers will also monitor whether participants develop other complications related to liver disease, such as variceal bleeding, fluid buildup in the abdomen (ascites), bacterial infections, confusion related to liver problems (hepatic encephalopathy), or the need for a liver transplant.
How the trial works: Participants will be randomly assigned to receive either Belapectin or a placebo (an inactive substance) through an intravenous injection. Neither the participants nor the study team will know which treatment is being given. The medication will be administered at a dose of either 2 mg/kg or 4 mg/kg based on lean body weight. Throughout the study, participants will undergo regular medical examinations and possibly imaging tests to monitor their liver condition and check for the development of varices. The study is expected to conclude by January 2028.
Investigational drug: Belapectin works by targeting a protein called galectin-3, which is involved in inflammation and the formation of scar tissue in the liver. By blocking this protein, the medication may help reduce liver scarring and prevent complications like esophageal varices. It is classified as an anti-fibrotic agent and is currently in phase 2b/3 clinical trials.
Who can participate:
- Adults between 18 and 75 years old
- Individuals with confirmed NASH cirrhosis, diagnosed through previous liver biopsy or imaging tests
- People showing signs of portal hypertension (high blood pressure in the liver’s blood vessels), indicated by low platelet counts, specific pressure measurements, enlarged spleen, visible abdominal blood vessels, increased liver stiffness, or elevated liver enzyme ratios
- Recent imaging (within 6 months) showing no liver cancer
- If diabetic, blood sugar must be well-controlled with stable medication for at least 3 months
- If taking vitamin E, pioglitazone, or statin medications, must be on a stable dose for at least 3 months
- Women of childbearing age must agree to use two effective methods of birth control and cannot be pregnant or breastfeeding
- Participants must be willing to sign informed consent
Who cannot participate:
- Individuals who already have esophageal varices
- Those outside the specified age range
- Pregnant or breastfeeding women
- People unable to give informed consent or understand study requirements
- Those with other serious health conditions that might interfere with the study
- Individuals currently participating in another clinical trial
- People who have recently had surgery or are planning surgery during the study period
- Those with known allergies to the study medication or its ingredients
- Individuals with a history of substance abuse or alcohol dependency
Summary
Currently, there is one active clinical trial focused on preventing esophageal varices in patients with NASH cirrhosis. This study is being conducted across five European countries: Belgium, France, Germany, Poland, and Spain, providing access to participants in multiple locations. The trial represents an important step in finding ways to prevent serious complications of liver disease before they develop, rather than only treating them after they occur.
The investigational drug Belapectin takes a novel approach by targeting galectin-3, a protein involved in liver scarring and inflammation. If successful, this medication could offer a new preventive option for patients with NASH cirrhosis who are at risk of developing esophageal varices but do not yet have them. The study will run for approximately 18 months per participant and will provide valuable information about both the effectiveness and safety of this treatment approach.