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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

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Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 11 Apr 2024

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At a glance

  • Drugs Belapectin (Primary)
  • Indications Liver cirrhosis; Non-alcoholic steatohepatitis; Oesophageal varices
  • Focus Registrational; Therapeutic Use
  • Acronyms NASH-RX; NAVIGATE
  • Sponsors Galectin Therapeutics

    • Most Recent Events

    • 09 Apr 2024 According to a Galectin Therapeutics media release, the company reported the positive outcome of its fifth independent DSMB meeting for NAVIGATE trial, The objective of this fifth DSMB meeting was to further review the emerging tolerance and safety profiles of belapectin. Based on its deliberation, which included an unblinded review of the data collected thus f
    • 23 Oct 2023 According to a Scholar Rock media release, top-line data expected from the Phase 2b portion in the fourth quarter of 2024.
    • 03 Oct 2023 According to a Galectin Therapeutics media release, company reported the positive outcome of its fourth data and safety monitoring board (DSMB) meeting for NAVIGATE, its seamless, adaptive, Phase 2b/3 study of belapectin in patients with portal hypertension caused by non-alcoholic steatohepatitis (NASH) liver cirrhosis.
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