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: Recruiting
Location: See all (37) 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
Arizona
Mayo Clinic Hospital
WITHDRAWN
Phoenix
California
Cedars Sinai Medical Center
WITHDRAWN
Los Angeles
University of California Davis Medical Center
RECRUITING
Sacramento
Washington, D.c.
Medstar Georgetown University Hospital
RECRUITING
Washington D.c.
Florida
Tampa General Hospital
RECRUITING
Tampa
Georgia
Piedmont Atlanta Hospital
RECRUITING
Atlanta
Minnesota
Mayo Clinic
RECRUITING
Rochester
Missouri
University of Missouri Health Care
RECRUITING
Columbia
New York
Columbia University Medical Center/ New York Presbyterian Hospital
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
The Liver Institute at Methodist Dallas
RECRUITING
Dallas
Baylor Clinic
RECRUITING
Houston
Virginia
Richmond VA Medical Center
RECRUITING
Richmond
Virginia Commonwealth University
RECRUITING
Richmond
Other Locations
Belgium
Universitair Ziekenhuis Antwerpen
RECRUITING
Edegem
Universitair Ziekenhuis Gent
WITHDRAWN
Ghent
Universitair Ziekenhuis Leuven
WITHDRAWN
Leuven
France
Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz
WITHDRAWN
Besançon
Centre Hospitalier Régional Universitaire de Tours
RECRUITING
Chambray-lès-tours
Hôpital de la Croix Rousse
RECRUITING
Lyon
Hôpital Universitaire Pitié Salpêtrière
RECRUITING
Paris
CHU Rennes - Hôpital Pontchaillou
RECRUITING
Rennes
Germany
Charité Universitätsmedizin Berlin
RECRUITING
Berlin
Medizinische Hochschule Hannover
RECRUITING
Hanover
Universitätsklinikum Jena
WITHDRAWN
Jena
Universitatsklinikum Munster
RECRUITING
Münster
Hungary
Debreceni Egyetem Klinikai Központ
RECRUITING
Debrecen
Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet
RECRUITING
Eger
Italy
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Azienda Ospedaliero-Universitaria Policlinico Umberto I
RECRUITING
Roma
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital University Of Vall d'Hebron-Vall d'Hebron Research Institute (VHIR)
WITHDRAWN
Barcelona
Hospital General Universitario Gregorio Marañón
WITHDRAWN
Madrid
Hospital Universitario Puerta de Hierro- Majadahonda
WITHDRAWN
Madrid
Hospital Universitario Ramón y Cajal
WITHDRAWN
Madrid
Hospital Universitari y Politècnic La Fe
WITHDRAWN
Valencia
Contact Information
Primary
Katharina Staufer, MD
clinical@versantis.com
+333 20 16 40 00
Time Frame
Start Date: 2023-07-02
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
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
Related Therapeutic Areas
Sponsors
Leads: Versantis AG