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Galactoarabino-Rhamnogalacturonate

This article discusses the ongoing clinical trials of Belapectin, also known as Galactoarabino-Rhamnogalacturonate, for the prevention of esophageal varices in patients with NASH cirrhosis. The study aims to evaluate the efficacy and safety of this innovative drug in addressing a significant complication of liver disease. We’ll explore the trial’s objectives, eligibility criteria, and potential impact on patient care.

Table of Contents

What is Belapectin?

Belapectin, also known as GR-MD-02, is an investigational medication being studied for its potential to prevent esophageal varices in patients with NASH cirrhosis[1]. The active substance in Belapectin is called galactoarabino-rhamnogalacturonate, which is a type of polymer (a large molecule made up of repeating subunits)[1].

Target Condition: Esophageal Varices in NASH Cirrhosis

NASH cirrhosis stands for Non-Alcoholic Steatohepatitis Cirrhosis. This is a severe form of liver disease that occurs when fat accumulates in the liver (fatty liver disease) and leads to inflammation, scarring, and eventually cirrhosis[1].

Esophageal varices are abnormally enlarged veins in the lower part of the esophagus (the tube connecting your throat to your stomach). They can develop in people with cirrhosis due to increased pressure in the portal vein, which carries blood from the intestines to the liver. These varices can potentially rupture and cause life-threatening bleeding[1].

Clinical Trial Details

A clinical trial is currently underway to evaluate the effectiveness and safety of Belapectin for preventing esophageal varices in patients with NASH cirrhosis. Here are some key details about the study[1]:

  • It’s a Phase 2b/3 study, which means it’s in an advanced stage of clinical research.
  • The study is double-blind, randomized, and placebo-controlled, ensuring that neither the patients nor the researchers know who is receiving the actual drug or a placebo.
  • It’s being conducted at multiple centers internationally.

Eligibility Criteria

The study has specific criteria for who can participate. Some key inclusion criteria are[1]:

  • Age between 18 and 75 years old
  • Evidence of portal hypertension (increased pressure in the portal vein)
  • Confirmed diagnosis of NASH cirrhosis
  • Absence of existing esophageal varices

Some exclusion criteria include[1]:

  • Presence of existing esophageal varices
  • History of liver decompensation (when the liver can no longer perform its normal functions)
  • Other causes of chronic liver disease besides NASH
  • Certain medication usage or medical conditions that might interfere with the study

Potential Benefits

The main goal of this study is to see if Belapectin can prevent the development of esophageal varices in patients with NASH cirrhosis. If successful, this could potentially reduce the risk of life-threatening bleeding events in these patients[1].

The study is also looking at other potential benefits, including[1]:

  • Prevention of other complications of cirrhosis, such as ascites (fluid buildup in the abdomen) and hepatic encephalopathy (brain dysfunction due to liver disease)
  • Potential impact on overall survival and need for liver transplantation
  • Effects on liver function as measured by the MELD score (a scoring system used to assess the severity of chronic liver disease)

Administration and Dosage

Belapectin is administered as a solution for injection given intravenously (directly into a vein). The study is testing two different doses[1]:

  • 2 mg/kg of lean body mass
  • 4 mg/kg of lean body mass

The maximum daily dose being tested is 4 mg/kg, and the treatment period may last up to 36 months (3 years)[1].

Aspect Details
Drug Name Belapectin (Galactoarabino-Rhamnogalacturonate)
Study Type Phase 2b/3, Double-Blind, Randomized, Placebo-controlled
Main Objective Evaluate efficacy in preventing esophageal varices in NASH cirrhosis
Dosage 2 mg/kg and 4 mg/kg lean body mass
Administration Intravenous injection
Primary Endpoint Proportion of patients developing esophageal varices at 78 weeks
Key Inclusion Criteria Age 18-75, NASH cirrhosis, evidence of portal hypertension
Key Exclusion Criteria Existing esophageal varices, liver decompensation history
Maximum Treatment Period 36 months

FAQ

  • What is Belapectin (Galactoarabino-Rhamnogalacturonate)? Belapectin, also known as Galactoarabino-Rhamnogalacturonate or GR-MD-02, is an investigational drug being studied for its potential to prevent esophageal varices in patients with NASH cirrhosis. It is a solution for injection administered intravenously.
  • What is the main goal of this clinical trial? The main goal of this trial is to evaluate the effectiveness of Belapectin in preventing the development of esophageal varices in patients with NASH cirrhosis. The study compares two doses (2 mg/kg and 4 mg/kg) of Belapectin to a placebo.
  • Who can participate in this clinical trial? Participants must be between 18 and 75 years old, have evidence of portal hypertension, and a confirmed diagnosis of NASH cirrhosis. They should not have existing esophageal varices or a history of liver decompensation. Other specific inclusion and exclusion criteria apply.
  • How long does the treatment last in this trial? The primary endpoint of the study is assessed at 78 weeks (18 months) of treatment. However, the maximum treatment period mentioned in the trial information is 36 months.
  • What are the potential benefits of Belapectin if successful? If successful, Belapectin could potentially prevent the development of esophageal varices in patients with NASH cirrhosis. This could lead to improved outcomes and quality of life for patients with this condition by reducing the risk of serious complications associated with portal hypertension.

Ongoing Clinical Trials on Galactoarabino-Rhamnogalacturonate

  • Study on Belapectin for Preventing Esophageal Varices in Patients with NASH Cirrhosis

    Not recruiting

    1 1
    Investigated drugs:
    Belgium France Germany Poland Spain

Glossary

  • NASH Cirrhosis: NASH stands for Non-Alcoholic Steatohepatitis. NASH Cirrhosis is an advanced stage of liver disease where the liver becomes scarred due to fat accumulation, inflammation, and cell damage, not caused by alcohol consumption.
  • Esophageal Varices: Enlarged veins in the lower part of the esophagus (food pipe) that can occur in people with advanced liver disease. These varices are at risk of bleeding, which can be life-threatening.
  • Portal Hypertension: Increased blood pressure in the portal vein system, which carries blood from the intestines to the liver. It's a common complication of cirrhosis.
  • Belapectin (Galactoarabino-Rhamnogalacturonate): An investigational drug being studied for its potential to prevent esophageal varices in patients with NASH cirrhosis. It's administered as an intravenous injection.
  • Placebo: A substance with no active therapeutic effect, used as a control in clinical trials to test the effectiveness of a new drug.
  • Lean Body Mass (LBM): The weight of your body minus the weight of your body fat. It includes muscle, organs, bones, and other non-fat tissues.
  • MELD Score: Model for End-Stage Liver Disease score, a numerical scale used to estimate the severity of chronic liver disease and prioritize patients for liver transplantation.
  • Child-Turcotte-Pugh (CTP) Score: A scoring system used to assess the prognosis of chronic liver disease and cirrhosis. It incorporates factors such as bilirubin levels, albumin levels, and presence of ascites or encephalopathy.
  • Hepatic Encephalopathy: A decline in brain function that occurs as a result of severe liver disease. It can lead to confusion, altered level of consciousness, and in severe cases, coma.
  • Ascites: Accumulation of fluid in the abdominal cavity, often seen in advanced liver disease.

References

  1. http://clinicaltrials.eu/trial/study-on-belapectin-for-preventing-esophageal-varices-in-patients-with-nash-cirrhosis/