GT-031: Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis
The purpose of this study is to find out about the safety and efficacy of Belapectin (GR-MD-002) for the prevention of esophageal varices in NASH (Non-Alcoholic Steatohepatitis) Cirrhosis. Belapectin is an investigational drug that has not been approved by Health Authorities in any country of the world, including the United States Food and Drug Administration (U.S. FDA). Belapectin (GR-MD-02) is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis (the origin and development of the disease) of fatty liver disease and fibrosis. The drug binds to galectin and disrupts its function. Preclinical data in animals have shown that Belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. Belapectin has been studied in clinical trials in patients with NASH cirrhosis and showed some evidence of potentially reducing the blood pressure in vessels entering cirrhotic liver and preventing the development of new esophageal varices (Enlarged veins). The esophagus is a muscular tube connecting the throat (pharynx) with the stomach and carries food and liquids to the stomach. The development of esophageal varices is one of the complications of cirrhosis and can cause unexpected and often severe bleeding in the digestive system.
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Who can participate?
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
- Has evidence of portal hypertension (MRI, CT or US confirmation as well as Endoscopy)
- Has a history confirming NASH cirrhosis by historical liver biopsy
- Must have stable use of Vitamin E or pioglitazone and statins for at least 3 months
- Patients with type 2 diabetes mellitus can be enrolled, if they are adequately controlled on a stable dose or doses of antidiabetic medication(s) for at least 3 months before study enrollment, and their screening HbA1c is 9.5%
- Must not be pregnant and agrees to use effective forms of contraception
- Presence of esophageal, gastroesophageal, or isolated gastric varices, based on an upper GI EGD exam conducted within 2 months of randomization
- History of hepatic cirrhosis decompensation including any episode of variceal bleeding, ascites not controlled by medication, spontaneous bacterial peritonitis or overt hepatic encephalopathy (West Haven grade 2 as assessed by the principal investigator), OR develops signs of hepatic cirrhosis decompensation after Screening but before randomization
- Known or suspected abuse of alcohol (>20 g/day for women or >30 g/day for men [on average per day]), as per medical history
- Prior trans-jugular intrahepatic portal-systemic (TIPS) shunt procedure
- History of bariatric surgery within 3 years of randomization, or plan to undergo weight reduction surgery or participate in weight reduction programs (eg, Weight Watchers®, Jenny Craig®) during the study
Will I be paid for my time?