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An Open Label, Randomized, Multicenter Study to Assess the Pharmacokinetic and Pharmacodynamic Profile and the Safety and Tolerability of Two Dose Levels of Elafibranor (80 mg and 120 mg) in Children and Adolescents, 8 to 17 Years of Age, With Nonalcoholic Steatohepatitis (NASH)

Trial Profile

An Open Label, Randomized, Multicenter Study to Assess the Pharmacokinetic and Pharmacodynamic Profile and the Safety and Tolerability of Two Dose Levels of Elafibranor (80 mg and 120 mg) in Children and Adolescents, 8 to 17 Years of Age, With Nonalcoholic Steatohepatitis (NASH)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 21 Sep 2023

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At a glance

  • Drugs Elafibranor (Primary)
  • Indications Non-alcoholic steatohepatitis
  • Focus Pharmacokinetics
  • Sponsors Genfit
  • Most Recent Events

    • 01 Aug 2023 Results assessing pharmacokinetics (PK), safety, and tolerability of oral elafibranor at 2 doses (80 and 120 mg) in children 8-17 years published in the Journal of Pediatric Gastroenterology and Nutrition
    • 30 Sep 2020 According to a Genfit media release, following its decision to terminate all development of Elafibranor in NASH, the Company decided to terminate this study.
    • 30 Sep 2020 Status changed from suspended to discontinued, according to a Genfit media release.
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