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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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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: 29 Aug 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

    • 30 May 2024 Planned End Date changed from 1 Aug 2024 to 1 Jun 2025.
    • 30 May 2024 Planned primary completion date changed from 1 Aug 2024 to 1 Mar 2025.
    • 29 May 2024 According to a Genfit media release, the company will be organizing an UNVEIL-IT meeting with investigators, key opinion leaders in ACLF, study team members and pharmacists to discuss the ongoing Phase 2 trial of VS-01 and to share study experiences. The meeting will provide a unique opportunity for investigators to gain insights and best practices from fellow investigators.

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