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A phase III study of a galectin-3 inhibitor, GR-MD-02 for the treatment of NASH cirrhosis patients without esophageal varices

Trial Profile

A phase III study of a galectin-3 inhibitor, GR-MD-02 for the treatment of NASH cirrhosis patients without esophageal varices

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 12 Nov 2019

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At a glance

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

    • 12 Nov 2019 According to a Galectin Therapeutics media release, The key milestones and associated target dates for the NASH-RX trial will be announced as elements of design of the trial are finalized based on the recent FDA feedback. However, the company expects he first patient to be enrolled in the first quarter of 2020.
    • 12 Nov 2019 According to a Galectin Therapeutics media release, based on updated feedback, the Company is redesigning the trial protocol. he Company plans to conduct an adaptive-designed trial, the primary endpoint would likely be a composite clinical outcomes endpoint, including varices requiring treatment (development of large varices or varices with a red wale), decompensated events, all-cause mortality, MELD score increase as defined earlier and liver transplant.
    • 12 Nov 2019 According to a Galectin Therapeutics media release, In its feedback the FDA seemingly is departing from its earlier implied potential support of the use of progression to varices as a surrogate endpoint for accelerated approval. he FDA also made additional constructive comments and suggestions mostly of an operational nature.
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