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

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What is this study about?

This clinical trial is focused on studying a condition known as esophageal varices, which can occur in people with NASH cirrhosis. NASH stands for Non-Alcoholic Steatohepatitis, a type of liver disease that can lead to cirrhosis, or severe liver scarring. The study is testing a treatment called Belapectin, also known by its code name GR-MD-02. Belapectin is given as a solution for injection and is being compared to a placebo to see if it can help prevent the development of esophageal varices in people with NASH cirrhosis.

The purpose of the study is to evaluate how effective and safe Belapectin is in preventing esophageal varices. Participants in the study will receive either Belapectin or a placebo. The study will last for about 18 months, during which time participants will receive regular injections and have their health monitored closely. The study aims to see if Belapectin can reduce the number of people who develop esophageal varices compared to those who receive a placebo.

Throughout the study, researchers will also look at other health outcomes, such as whether participants develop other complications related to liver disease, like variceal bleeding or ascites, which is fluid buildup in the abdomen. The study will help determine if Belapectin can be a beneficial treatment for people with NASH cirrhosis to prevent these serious complications.

1 Joining the study

Upon joining the study, the patient will be randomly assigned to receive either the investigational medication belapectin or a placebo. This process is double-blind, meaning neither the patient nor the study team will know which treatment is being administered.

2 Medication administration

The patient will receive belapectin or placebo through an intravenous injection. The dosage of belapectin will be either 2 mg/kg or 4 mg/kg based on lean body mass. The frequency and duration of administration will be determined by the study protocol.

3 Monitoring and assessments

Throughout the study, the patient will undergo regular monitoring to assess the development of esophageal varices. This includes medical examinations and possibly imaging tests to evaluate the condition of the liver and the presence of varices.

4 Primary evaluation

The primary goal is to determine the proportion of patients who develop esophageal varices after 78 weeks (approximately 18 months) of treatment with belapectin compared to placebo.

5 Secondary evaluation

Secondary outcomes include the incidence of complications such as variceal bleeding, ascites, bacterial infections, hepatic encephalopathy, and the need for liver transplantation. Mortality rates and changes in liver disease severity scores will also be monitored.

6 Completion of the study

The study is expected to conclude by January 14, 2028. At the end of the study, the data collected will be analyzed to determine the efficacy and safety of belapectin in preventing esophageal varices in patients with NASH cirrhosis.

Who Can Join the Study?

Must be a male or female between 18 and 75 years old.
If capable of having children, must agree to use two effective methods of birth control, one of which must be a physical barrier like a condom.
If a woman is breastfeeding, she must agree to stop nursing before starting the study and for 90 days after the last dose of the study treatment.
If a man, must agree not to donate sperm during the study and for 90 days after the last dose of the study treatment. If a woman, must not start any egg donation or harvesting during the study and for 90 days after the last dose of the study treatment.
Must be willing and able to sign a written consent form to participate in the study.
Must have signs of portal hypertension, which is high blood pressure in the vein that carries blood to the liver. This can be shown by one of the following:
- A platelet count less than 150,000 per mm³.
- A HVPG measurement greater than 6 mmHg, which is a test that measures pressure in the liver.
- At least two of the following: a spleen size of 14 cm or more, visible blood vessels in the abdomen, a liver stiffness measurement of 20 kPa or more, or a ratio of AST/ALT greater than 1 (these are liver enzymes).
Must have a history of NASH cirrhosis, which is a type of liver disease, confirmed by one of the following:
- A past liver biopsy showing cirrhosis with steatohepatitis (a type of liver inflammation).
- A past liver biopsy showing steatohepatitis and evidence of cirrhosis from other tests or a second biopsy.
- A past liver biopsy showing cirrhosis with steatosis (fat in the liver) but not steatohepatitis.
- A past liver biopsy showing steatosis but now with cirrhosis confirmed by other tests.
- Current or past imaging showing steatosis with cirrhosis.
- If none of the above, a new liver biopsy is needed.
Must not have HCC, which is a type of liver cancer, confirmed by imaging within 6 months before joining the study.
If having type 2 diabetes, must be well-controlled on stable diabetes medication for at least 3 months before the study, with a blood sugar level (HbA1c) of 9.5% or less.
If taking vitamin E or pioglitazone (a diabetes medication), must have been on a stable dose for at least 3 months before the study, and the dose should remain the same during the study.
If taking a statin (a cholesterol-lowering medication), must have been on a stable dose for at least 3 months before the study, and the dose should remain the same during the study.
Must not be pregnant and must have a negative pregnancy test before joining the study.

Who Cannot Join the Study?

Patients who have a history of esophageal varices. These are swollen veins in the esophagus, which is the tube that carries food from the mouth to the stomach.
Patients with NASH cirrhosis. This is a liver condition where the liver becomes scarred due to fat buildup, not related to alcohol use.
Patients who are not within the specified age range for the study.
Patients who are not able to give informed consent or understand the study requirements.
Patients who are pregnant or breastfeeding.
Patients with other serious health conditions that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who have a known allergy to the study medication or its ingredients.
Patients who have a history of substance abuse or alcohol dependency.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Del Mar	Barcelona	Spain
Az Maria Middelares Gent	Gent	Belgium
Eugastro GmbH	Leipzig	Germany
ID Clinic	Myslowice	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Hopital Beaujon	Clichy	France
Hcclohvp Uwzcbkukqqgzh Mdiuheb Dg Vwnixacmdt	Santander	Spain
Uzlheqrxwa Oq Agwhxua	Edegem	Belgium
Ckp Ctuhr Rqqcawamesv	Lyon	France
Hguvzxcw Uulclwsujkdebj Sioombsvde &hsrszv Hgqkmcd dx Hyqnusyhogy	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	25.06.2020
France	Not recruiting	25.06.2020
Germany	Not recruiting	25.06.2020
Poland	Not recruiting	25.06.2020
Spain	Not recruiting	25.06.2020

Trial locations

Investigated drugs:

Galactoarabino-Rhamnogalacturonate

Belapectin (GR MD-02) is a medication being studied for its potential to prevent the development of esophageal varices in patients with NASH cirrhosis. Esophageal varices are enlarged veins in the esophagus that can cause serious bleeding. This medication is being tested to see if it can help stop these veins from forming, which could reduce the risk of bleeding and other complications in people with liver disease.

Esophageal Varices in NASH Cirrhosis – Esophageal varices are enlarged veins in the esophagus, which can occur due to increased pressure in the portal vein, often seen in cirrhosis. In the context of NASH (Non-Alcoholic Steatohepatitis) cirrhosis, the liver becomes scarred and damaged due to fat accumulation and inflammation, leading to increased portal pressure. As the disease progresses, these varices can become more pronounced and are at risk of bleeding. The development of esophageal varices is a significant complication in patients with cirrhosis, as it indicates advanced liver disease. Monitoring and managing these varices are crucial to prevent serious complications.

Trial ID:

2024-512619-28-00

Protocol code:

GT-031

NCT ID:

NCT04365868

Trial Phase:

Therapeutic use (Phase IV)

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

What is this study about?

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Who Cannot Join the Study?