A Seamless Adaptive Phase 2b/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 Cirrhosis

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Non-alcoholic Steatohepatitis (nash) Cirrhosis
  • Age: Between 15 years - 75 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants who are willing and able to provide written informed consent prior to the initiation of any study-specific procedures.
    2. Has evidence of portal hypertension
    3. Has a history confirming NASH cirrhosis
    4. Absence of hepatocellular carcinoma(HCC) by valid imaging
    5. Participants 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
    6. Participants on vitamin E or pioglitazone can be enrolled if they are on a stable dose and regimen for at least 3 months before screening
    7. Participants on a statin can be enrolled if they are on a stable dose and regimen for at least 3 months before screening
    8. Those who are not pregnant and must have a negative serum pregnancy test result prior to randomization.
    9. Fertile men and women agree to use two acceptable means of contraception
    10. If a lactating woman, agrees to discontinue nursing before the start of study treatment and refrain from nursing until 90 days after the last dose of study treatment.

You may not be eligible for this study if the following are true:

    1. Presence of esophageal, gastroesophageal, or isolated gastric varices,
    2. History of hepatic cirrhosis decompensation
    3. Known or suspected abuse of alcohol
    4. Alcohol dependence
    5. Narcotics or any other drug abuse or dependence in the last 5 years
    6. Prior trans-jugular intrahepatic portal-systemic (TIPS) shunt procedure
    7. Documented causes of chronic liver disease other than NASH
    8. Type 1 diabetes or poorly controlled Type 2 diabetes mellitus
    9. History of human immunodeficiency virus (HIV), or positive HIV test at Screening
    10. Laboratory test results as per the protocol
    11. History of major surgery within 8 weeks of randomization
    12. History of a solid organ transplant requiring continuing immunosuppressive therapy.
    13. History of bariatric surgery within 3 years of randomization
    14. Has positive screening test for illicit drugs of abuse
    15. Has participated in an investigational new drug study within 30 days
    16. Has a history of malignancy
    17. Has a history of clinically significant hematologic, renal, hepatic, pulmonary, neurological, psychiatric, gastrointestinal, systemic inflammatory, metabolic or endocrine disorder or any other condition that, in the opinion of the Investigator, renders the subject a poor candidate for inclusion into the study
    18. Has known allergies to the IMP
    19. Has previously received belapectin within 6 months of randomization

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.