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A Seamless, Adaptive, Phase2b/3, Double-blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirhosis
This trial will evaluate the study drug Belapectin in patients with NASH (Non-Alcoholic Steatohepatitis) Cirrhosis. The purpose of this voluntary research study is to find out about the safety and efficacy of the study drug and for the prevention of esophageal varices in NASH Cirrhosis. .
If you consent to participate, you will be asked to have some screening tests and procedures, as described in the table below. This period of up to 3 visits within 2 months is called Screening Period. Based upon results of tests and procedures completed during these visits, your study doctor will be able to decide if you meet the requirements to participate in this study. If you meet the study requirements to participate in this study, your study doctor will discuss with you when you should start the study treatment.
early stage cirrhosis
diagnosis of NASH
substance abuse
other liver disease
history of organ transplant