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A Phase 2a, open-label, randomized, controlled, multi-center, proof of concept study, to assess the efficacy, safety and tolerability of VS-01 on top of standard of care, compared to standard of care alone, in adult patients with acute-on-chronic liver failure (ACLF) grades 1 and 2 and ascites

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Trial Profile

A Phase 2a, open-label, randomized, controlled, multi-center, proof of concept study, to assess the efficacy, safety and tolerability of VS-01 on top of standard of care, compared to standard of care alone, in adult patients with acute-on-chronic liver failure (ACLF) grades 1 and 2 and ascites

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 25 Apr 2024

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At a glance

  • Drugs Citric acid (Primary)
  • Indications Ascites; Hepatic encephalopathy; Liver cirrhosis; Liver failure
  • Focus Adverse reactions; First in man; Proof of concept; Therapeutic Use
  • Acronyms UNVEIL; UNVEIL-IT
  • Sponsors Versantis
  • Most Recent Events

    • 04 Apr 2024 According to a Genfit media release, Topline interim data expected in 2H24
    • 06 Feb 2024 Maximum age limit for inclusion criteria is increased from 64 to 69 years, thus including elderly patients as well.
    • 16 Nov 2023 According to Genfit media release, interim data readout targeted for the end of 2Q24
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