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)
Status: Terminated
Location: See all (26) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
University of California Davis Medical Center
Sacramento
Washington, D.c.
Medstar Georgetown University Hospital
Washington D.c.
Florida
Tampa General Hospital
Tampa
Georgia
Piedmont Atlanta Hospital
Atlanta
Minnesota
Mayo Clinic
Rochester
Missouri
University of Missouri Health Care
Columbia
New York
Columbia University Medical Center/ New York Presbyterian Hospital
New York
Ohio
Cleveland Clinic
Cleveland
South Carolina
Medical University of South Carolina
Charleston
Texas
The Liver Institute at Methodist Dallas
Dallas
Baylor Clinic
Houston
Virginia
Richmond VA Medical Center
Richmond
Virginia Commonwealth University
Richmond
Other Locations
Belgium
Universitair Ziekenhuis Antwerpen
Edegem
France
Centre Hospitalier Régional Universitaire de Tours
Chambray-lès-tours
Hôpital de la Croix Rousse
Lyon
Hôpital Universitaire Pitié Salpêtrière
Paris
CHU Rennes - Hôpital Pontchaillou
Rennes
Germany
Charité Universitätsmedizin Berlin
Berlin
Medizinische Hochschule Hannover
Hanover
Universitatsklinikum Munster
Münster
Hungary
Debreceni Egyetem Klinikai Központ
Debrecen
Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet
Eger
Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Roma
Spain
Hospital Clínic de Barcelona
Barcelona
Time Frame
Start Date:2023-07-02
Completion Date:2025-10-15
Participants
Target number of participants:15
Treatments
Experimental: VS-01 on top of SOC (Active Treatment Group)
Patients randomized to Active Treatment group will receive VS-01 on top of SOC
Other: SOC (Control Group)
Patients randomized to Control group will receive SOC defined as the standard medical management of patients with decompensated cirrhosis and ACLF