A Multicenter, Randomized, Placebo-controlled, Double-blind, Parallel-group, Phase 2 Clinical Trial to Evaluation the Safety and Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis and Resultant Portal Hypertension in Patients With Nash Cirrhosis

Trial Profile

A Multicenter, Randomized, Placebo-controlled, Double-blind, Parallel-group, Phase 2 Clinical Trial to Evaluation the Safety and Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis and Resultant Portal Hypertension in Patients With Nash Cirrhosis

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 14 Aug 2017

At a glance

  • Drugs GR MD 02 (Primary)
  • Indications Liver cirrhosis; Non-alcoholic steatohepatitis
  • Focus Therapeutic Use
  • Acronyms NASH-CX
  • Sponsors Galectin Therapeutics
  • Most Recent Events

    • 14 Aug 2017 According to a Galectin Therapeutics media release, the company expect approximately 151 subjects will complete the trial by September 2017.
    • 13 Jun 2017 According to a Galectin Therapeutics media release, this trial is being conducted with a primary endpoint that the U.S. Food and Drug Administration views may be a surrogate for outcomes for registration trials in this patient population
    • 13 Jun 2017 According to a Galectin Therapeutics media release, in the third meeting the independent data safety monitoring board (DSMB), has concluded from a safety perspective that company should continue this trial. At the time of evaluation, therapy had been completed in 68% of subjects in this trial.
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