EUCTR2021-002617-33-DE
Active, not recruiting
Phase 1
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 - UNVEIL-IT
ConditionsAcute-on-chronic liver failure (ACLF) is characterized by hepatic andextrahepatic organ dysfunction and/or failure and highly activatedsystemic inflammation. It leads to an accumulation of different metabolites, interalias ammonia, which cannot be metabolized.Hyperammonemia leads to Hepatic Encephalopathy (HE). ACLF is amajor cause of death in cirrhosis, with an approximately 50% mortality rate. The selected patient population is ACLF grade 1 and 2 patients with ascites.MedDRA version: 24.0Level: PTClassification code 10077305Term: Acute on chronic liver failureSystem Organ Class: 10019805 - Hepatobiliary disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute-on-chronic liver failure (ACLF) is characterized by hepatic andextrahepatic organ dysfunction and/or failure and highly activatedsystemic inflammation. It leads to an accumulation of different metabolites, interalias ammonia, which cannot be metabolized.Hyperammonemia leads to Hepatic Encephalopathy (HE). ACLF is amajor 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
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with liver cirrhosis, diagnosed by standard clinical criteria, imaging findings and/or histology with any underlying etiology;
- •2\. Patients with liver cirrhosis and 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 or 2;
- •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;
- •d. Circulatory failure (dopamine \=15 µg/kg/min, or epinephrine \= 0\.1 µg/kg/min, or norepinephrine \= 0\.1 µg/kg/min) with either kidney dysfunction (serum creatinine \= 1\.5 \- \< 2\.0 mg/dL) and/or HE grade 1 or 2;
- •e. Brain failure (HE West Haven grade 3\) \+ kidney dysfunction (serum creatinine \= 1\.5 \- \< 2\.0 mg/dL).
- •ACLF grade 2 patients meeting one of the following:
- •f. Kidney failure (serum creatinine \= 2 mg/dL) without RRT \+ brain failure (HE West Haven grade 3\);
Exclusion Criteria
- •1\. Patients with acute or sub\-acute liver failure without underlying cirrhosis;
- •2\. Presence of the following organ failure(s) as per the EASL\-CLIF criteria and/or adapted from CLIF\-C OF/CLIF\-SOFA scores:
- •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 109/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;
- •d. HE West Haven grade 4
- •3\. ACLF grade 3: Presence of three or more organ failures as per EASLCLIF criteria as described in the EASL\-Clinical Practice Guideline on decompensated liver cirrhosis; organ failures will be calculated based on CLIF\-C OF score);
- •4\. Presence of spontaneous or secondary bacterial peritonitis:
- •a. presence of neutrophils in a normally sterile body fluid (i.e., neutrophil counts \> 250/mm3 in ascitic fluid);
- •5\. Presence of spontaneous bacterial pleural empyema:
Outcomes
Primary Outcomes
Not specified
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