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VS-01

DRUG2 trials

Sponsors

Versantis AG

Conditions

2 or 3a patients.Acute-on-chronic liver failure (ACLF) is characterized by hepatic and extrahepatic organ dysfunction and/or failure and highly activated systemic inflammation. It leads to an accumulation of different metabolitesPatients with overt hepatic encephalopathy (OHE) and acute decompensation (AD) of liver cirrhosis or acute-on chronic liver failure (ACLF) grade 1interalias ammoniawhich cannot be metabolized. Hyperammonemia leads to Hepatic Encephalopathy (HE). ACLF is a major cause of death in cirrhosiswith an approximately 50% mortality rate. The selected patient population is ACLF grade 1

Phase 2

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)
CompletedCTIS2024-513706-56-00
Versantis AG2 or 3a patients., Acute-on-chronic liver failure (ACLF) is characterized by hepatic and extrahepatic organ dysfunction and/or failure and highly activated systemic inflammation. It leads to an accumulation of different metabolites, interalias ammonia +2
Start: 2023-03-22End: 2025-10-15Target: 102Updated: 2025-07-01
A Phase 2, Randomized, Controlled, Open Label, Adaptive Dose Design, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Two Different Dwell Times of VS-01 on Top of Standard of Care versus Standard of Care Alone in Patients with Overt Hepatic Encephalopathy
CompletedCTIS2025-521029-34-00
Versantis AGPatients with overt hepatic encephalopathy (OHE) and acute decompensation (AD) of liver cirrhosis or acute-on chronic liver failure (ACLF) grade 1
Start: 2025-09-18End: 2025-09-19Target: 30Updated: 2025-08-21