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) grades 1 and 2 and ascites - UNVEI

Versantis AG0 sites60 target enrollmentAugust 30, 2022

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Acute-on-chronic liver failure (ACLF) is characterized by hepatic and extrahepatic organ dysfunction and/or failure and highly activated systemic inflammation. It leads to an accumulation of different metabolites, 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 1 and 2 patients with ascites.
Sponsor: Versantis AG
Enrollment: 60
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

August 30, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Cirrhotic patients diagnosed by standard clinical criteria, imaging
•findings and/or histology with any underlying etiology;
•2\. Cirrhotic patients with ACLF Grade 1 or 2 (according to EASL\-CLIF
•criteria as described in the EASL\-Clinical Practice Guideline on decompensated liver cirrhosis (EASL Clinical Practice Guidelines, 2018\); organ failures will be calculated based on the CLIF\-C OF score) triggered by any acute insult other than those listed in the exclusion criteria:
•ACLF grade 1 patients meeting one of the following:
•a. Single kidney failure (serum creatinine \= 2 mg/dL) without RRT \+/\-
•liver, cerebral, coagulation, circulation or respiratory dysfunction;
•b. Liver failure (serum bilirubin \= 12\.0 mg/dL) with either kidney
•dysfunction (serum creatinine \= 1\.5 – \< 2\.0 mg/dL) and/or HE grade 1
•c. Coagulation failure (International Normalized Ratio \[INR] \= 2\.5 \- \= 3\.0\) with either kidney dysfunction (serum creatinine \= 1\.5 \- \< 2\.0 mg/dL) and/or HE grade 1 or 2;

•1\. Patients with acute or sub\-acute liver failure without underlying
•2\. Presence of the following organ(s) failure(s) as per the EASL definitions and CLIF\-C OF score:
•a. Respiratory failure as defined by Partial pressure of oxygen (PaO2\)/
•Fraction of inspired oxygen (FiO2\) \= 200, or oxygen saturation
•(SpO2\)/FiO2 \= 214 or mechanical ventilation;
•b. Coagulation failure with an INR \> 3\.0 or platelet count \= 20 x 09/L;
•c. Severe cardiovascular failure requiring the use of vasopressors
•(dopamine \>15 µg/kg/min, or epinephrine \> 0\.1 µg/kg/min, or
•norepinephrine \> 0\.1 µg/kg/min). It should be clarified that the use of terlipressin or low\-dose norepinephrine in case of hepatorenal syndrome (HRS) is not an exclusion criterion;
•3\. ACLF grade 3: Presence of three or more organ failures as per