- Ongoing, recruitingTherapeutic exploratory (Phase II)
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
This study is testing a new treatment called VS-01 for people with a serious liver condition called hepatic encephalopathy. It aims to see how well VS-01 helps improve confusion and other symptoms, how safe it is, and how the body uses it, compared to standard care.
For: Patients with overt hepatic encephalopathy (OHE) and acute decompensation (AD) of liver cirrhosis or acute-on chronic liver failure (ACLF) grade 1Germany · Belgium · Spain - Ongoing, recruitingTherapeutic exploratory (Phase II)
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)
This study is looking at a new treatment called VS-01 for adults with a serious liver condition called acute-on-chronic liver failure (ACLF). It compares VS-01 with standard care to see if it's safe and helps improve liver health.
For: interalias ammonia · which cannot be metabolized. Hyperammonemia leads to Hepatic Encephalopathy (HE). ACLF is a major cause of death in cirrhosis · with an approximately 50% mortality rate. The selected patient population is ACLF grade 1Germany · Belgium · Spain