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Study on the Effects of VS-01 for Adults with Acute-on-Chronic Liver Failure and Ascites

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as acute-on-chronic liver failure (ACLF), which occurs when someone with long-term liver disease experiences a sudden worsening of their liver function. This can lead to problems with other organs and cause a buildup of harmful substances in the body, such as ammonia. This buildup can result in a condition called hepatic encephalopathy, which affects the brain and can lead to confusion and other mental changes. The trial is specifically looking at patients with ACLF grades 1 and 2 who also have a condition called ascites, where fluid accumulates in the abdomen.

The study is testing a new treatment called VS-01, which is given as a suspension for infusion directly into the abdominal cavity. The purpose of the study is to evaluate how effective, safe, and tolerable VS-01 is when used alongside the standard care that patients with ACLF already receive. Some patients will receive VS-01 in addition to their usual treatment, while others will continue with their standard care alone. The study will last for a short period, with the treatment being administered daily over four days.

Participants in the study will be monitored to see how their condition changes over time, with a particular focus on their CLIF-C ACLF score, which is a measure used to assess the severity of ACLF. The study will also look at other outcomes, such as survival rates and any side effects related to the treatment. The goal is to determine whether adding VS-01 to the standard care can improve outcomes for patients with ACLF and ascites.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of liver cirrhosis and acute-on-chronic liver failure (ACLF) grades 1 or 2.

    Informed consent is required, either signed by the patient or a legal representative.

  2. Step 2

    Treatment phase

    The treatment involves the administration of the medicinal product VS-01, which is a suspension for infusion.

    The product is administered intraperitoneally (into the abdominal cavity) once daily for a total of 4 days.

    This treatment is given in addition to the standard care that the patient is already receiving.

  3. Step 3

    Monitoring and assessment

    The primary goal is to evaluate the effectiveness of VS-01 by measuring the Chronic Liver Failure Consortium Acute on-Chronic Liver Failure (CLIF-C ACLF) score on Day 7.

    Secondary assessments include monitoring mortality rates at 28 and 90 days, changes in ACLF grade, and transplant-free survival.

    Safety is also evaluated by recording any adverse reactions related to VS-01.

  4. Step 4

    Follow-up

    The study includes follow-up assessments to track the patient's condition and any long-term effects of the treatment.

    The estimated end date for the trial is June 30, 2025.

Who can join the trial?

7 criteria

  • Patients must have **liver cirrhosis**, which is a condition where the liver is scarred and damaged, diagnosed by standard medical methods.
  • Patients should have **ACLF Grade 1 or 2**, which is a specific level of liver failure, caused by a sudden worsening of liver function.
  • The **ACLF** condition must have started no more than 7 days before the screening for the study.
  • Patients must have **ascites**, which is a buildup of fluid in the abdomen, requiring a procedure called **paracentesis** to remove the fluid.
  • Patients should have a **dry body weight** (weight without extra fluid) of at least 40 kg and less than 140 kg.
  • Participants must be between **18 and 79 years old** on the day they sign the consent form.
  • Patients must be able to understand and sign the **Patient Informed Consent Document (PICD)**, or have a legal representative sign it for them, following local laws and policies.

Who cannot join the trial?

9 criteria

  • Patients with **severe liver failure** beyond grade 2 cannot participate. This means their liver is not working well enough.
  • Patients with **other serious organ failures** besides the liver are excluded. This means if other important organs like the heart or kidneys are not working properly, they cannot join.
  • Patients with **uncontrolled infections** are not allowed. This means if they have an infection that is not being managed or treated effectively, they cannot participate.
  • Patients who are **pregnant or breastfeeding** cannot take part in the study.
  • Patients with **known allergies** to the study medication or its ingredients are excluded. This means if they have had allergic reactions to similar treatments before, they cannot join.
  • Patients who have **participated in another clinical trial** recently are not eligible. This means if they have been part of another study in the past few weeks or months, they cannot participate.
  • Patients with **mental health conditions** that might affect their ability to follow the study instructions are excluded. This means if they have conditions that make it hard to understand or remember instructions, they cannot join.
  • Patients with **substance abuse issues** are not allowed. This means if they have problems with drugs or alcohol, they cannot participate.
  • Patients who have had a **liver transplant** are excluded. This means if they have received a new liver from a donor, they cannot join the study.
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Investigated drugs

VS-01 is a medication being tested for its effectiveness in treating patients with acute-on-chronic liver failure (ACLF) grades 1 and 2. It is administered directly into the abdominal cavity once a day for four days. The study aims to see if adding VS-01 to the standard treatment improves patient outcomes compared to the standard treatment alone.

What is already known about the treatment

VS-01 – This medication is administered intraperitoneally, meaning it is delivered directly into the abdominal cavity. It is currently being studied in clinical trials for its potential use in treating acute-on-chronic liver failure (ACLF), particularly in patients with grades 1 and 2 who have ascites. The main therapeutic indication for VS-01 is to improve liver function and reduce systemic inflammation associated with ACLF. At the molecular level, it works by targeting and reducing the accumulation of harmful metabolites like ammonia, which can lead to hepatic encephalopathy. VS-01 is classified pharmacologically as a treatment for liver conditions, specifically focusing on reducing complications from liver failure.

Investigated diseases

Acute-on-chronic liver failure (ACLF) – This condition involves the sudden worsening of liver function in individuals with pre-existing chronic liver disease. It is marked by the failure of the liver and potentially other organs, alongside a heightened inflammatory response throughout the body. The liver's inability to process certain substances, such as ammonia, can lead to complications like hepatic encephalopathy, which affects brain function. Patients with ACLF often experience fluid accumulation in the abdomen, known as ascites. The condition is categorized into different grades, with grades 1 and 2 indicating varying levels of severity.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513706-56-00Protocol codeVS01-IIa-01Estimated enrolment115 patientsSponsorVersantis AG

sourced from the EU Clinical Trials Register and site verification

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