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
Latest Information Update: 29 Aug 2024
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
- 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.