Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure … (NCT05900050) | Clinical Trial Compass
TerminatedPhase 2
Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®
Stopped: Sponsor Decision
United States15 participantsStarted 2023-07-02
Plain-language summary
A Phase 2, multi-center, randomized, controlled, open-label study to evaluate the effects of the intraperitoneal, liposomal formulation VS-01 in patients with an acute episode of hepatic and/or extrahepatic organ dysfunctions and failures in the presence of liver cirrhosis (Acute-on-Chronic Liver Failure, ACLF) and accumulation of fluid in the abdominal cavity (ascites)
Who can participate
Age range18 Years – 79 Years
SexALL
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Inclusion criteria
✓. Patients with ACLF Grade 1, 2, or 3a according to European Association for the Study of the Liver (EASL)-CLIF criteria;
✓. Onset of ACLF not more than 14 days before Baseline (BL);
✓. Presence of ascites requiring diagnostic or therapeutic paracentesis;
✓. Patients with dry body weight ≥40 and \<140 kg;
✓. Written informed consent obtained prior to the start of any study-related procedures.
Exclusion criteria
✕. Presence of any of the following organ failure(s) as per the EASL-CLIF criteria and/or adapted from CLIF-C Organ Failure (CLIF-C OF)/CLIF- Sequential Organ Failure Assessment (CLIF-SOFA) scores: