Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®

A vizsgálat adatai

Ki végzi

Genfit

Azonosító

NCT05900050EU 2024-513706-56-00

A regiszteradat frissítve

2026. július 23.

Eredeti leírás

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)A teljes eredeti leírásKevesebb

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)

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)

Bevonási feltételek: 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.

Kizáró feltételek: Patients with history of upper gastro-intestinal bleeding over the past 7 days prior to BL, acute bleeding or bleeding upon paracentesis at screening (SCR) or BL; Patients after organ transplantation receiving immunosuppressive medication; Need for Renal Replacement Therapy or any extracorporeal liver support device (e.g., MARS®, Prometheus®, plasmapheresis); Patients who participate in another clinical trial at the time of SCR or within 4 weeks prior to SCR; Presence of uncontrolled severe infection(with hemodynamic instability or shock); Poorly controlled seizure disorder; Coagulation disorders such as disseminated intravascular coagulation or hemophilia; Potential or known hypersensitivity to liposomes; Potential or known risk factors for allergic/anaphylactoid like reactions (e.g., mastocytosis/elevated basal tryptase) or multiple hypersensitivities; Any severe disease considered to be potentially detrimental at the discretion of the Principal Investigator. This includes but is not limited to hepatocellular carcinoma outside Milan criteria, cholangiocarcinoma, extrahepatic cancer over the past 2 years or people who inject drugs; 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:; Respiratory failure necessitating invasive mechanical ventilation; Coagulation failure (INR > 3.2 or platelet count ≤20 x 109/L); Severe cardiovascular failure requiring the use of high dose vasopressors; ACLF grade 3b: Presence of four or more organ failures as per EASL CLIF criteria; Presence of spontaneous or secondary bacterial peritonitis; Contraindication for paracentesis; Alfapump® in place to manage ascites; Pregnancy and lactation; Women of child-bearing potential who are not willing to use adequate contraception.

ClinicalTrials.gov NCT05900050 · EU CTIS 2024-513706-56-00