Title: Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis
Associated condition: NASH
Status: Currently enrolling
Brief summary: This is a seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study. Subjects will be assigned to one of three treatment arms for each of the two stages: subjects in the first experimental arm will receive belapectin 2 mg/kg lean body mass (LBM) administered intravenously (IV) every other week for 78 weeks in Phase 2b, then switch to the optimal dose in Phase 3; in another experimental arm, subjects will receive belapectin 4 mg/kg LBM IV every other week for 78 weeks in Phase 2b then switch to the optimal dose in Phase 3; those in the placebo comparator group will receive IV placebo every other week for both Phase 2b and Phase 3.
Primary objectives: To evaluate the efficacy, tolerability, and safety of belapectin (GR-MD-02) for the prevention of esophageal varices in NASH cirrhosis.
Estimated length of study: 18 months, with a study start date of June 22, 2020 and an estimated end date of December 22, 2021
For more detailed information on this research trial, including eligibility and study design, please visit the clinical trial page at U.S. National Library of Medicine’s website. Note you can submit your information for consideration by submitting the contact form on this page.
