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Study of VS-01 with different treatment times compared to standard care alone in patients with overt hepatic encephalopathy and liver cirrhosis complications

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This study focuses on patients with overt hepatic encephalopathy, a condition that affects brain function due to advanced liver disease. The condition occurs in people who have liver cirrhosis with sudden worsening of symptoms or acute complications. The study will test a new investigational medicine called VS-01, which is given as a suspension through the abdominal cavity, in addition to regular standard treatment.

The purpose of this research is to determine if VS-01 can help treat overt hepatic encephalopathy when given once daily for up to 4 days. The study will compare two different treatment durations (3 hours and 4 hours) of VS-01 combined with standard care against standard care alone. The medication contains citric acid as its main component and is administered through intraperitoneal delivery, which means it is given directly into the abdominal cavity.

During the study, patients will receive either VS-01 with standard treatment or standard treatment alone. The treatment period lasts up to 4 days, during which doctors will monitor how quickly patients' symptoms improve. The study will also look at how the body processes the medication and track any changes in blood and abdominal fluid composition to ensure the treatment is safe.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your blood ammonia levels will be checked to confirm they are above normal limits

    Your liver condition will be evaluated to confirm cirrhosis and presence of ascites (excess fluid in the abdomen)

    Your body weight will be measured to ensure it is between 40 and 140 kg

  2. Step 2

    Treatment group assignment

    You will be randomly assigned to one of three groups:

    Group 1: Standard care only

    Group 2: Standard care plus VS-01 with 3-hour treatment duration

    Group 3: Standard care plus VS-01 with 4-hour treatment duration

  3. Step 3

    Treatment period

    The treatment will last up to 4 days

    If you are in group 2 or 3, you will receive VS-01 once daily through a tube into your abdominal cavity

    The medication will remain in your abdomen for either 3 or 4 hours, depending on your assigned group

    Blood samples will be taken to measure ammonia levels and medication concentrations

    Samples of fluid from your abdomen will also be collected for testing

  4. Step 4

    Monitoring

    Your vital signs will be regularly checked

    You will have heart rhythm tests (ECG)

    Laboratory tests will be performed to monitor your condition

    Your mental state will be assessed regularly to track improvements in hepatic encephalopathy (brain function changes due to liver disease)

  5. Step 5

    Safety assessment

    Any side effects or health changes will be recorded and evaluated

    The study team will monitor your overall response to the treatment

Who can join the trial?

7 criteria

  • You must have liver cirrhosis (scarring of the liver) confirmed by clinical tests, imaging, or tissue examination, along with hepatic encephalopathy (brain dysfunction caused by liver disease)
  • You must have ascites (fluid buildup in the abdomen) that requires drainage through a medical procedure
  • Your blood ammonia levels must be higher than normal when tested before starting the study
  • Your dry body weight must be between 40 kg and 140 kg (88-308 pounds)
  • You must be between 18 and 79 years old when you sign the consent form
  • You must be willing and able to provide written consent to participate. If you cannot give consent yourself, a legally authorized representative can sign on your behalf according to local laws
  • Both men and women can participate in the study

Who cannot join the trial?

12 criteria

  • Patients with severe liver failure (beyond grade 1 acute-on chronic liver failure)
  • Patients below 18 years of age
  • Patients with known allergies to the study medication
  • Pregnant or breastfeeding women
  • Patients with severe kidney problems requiring dialysis
  • Patients with active gastrointestinal bleeding
  • Patients with unstable vital signs (unstable blood pressure, heart rate, or breathing)
  • Patients currently participating in other clinical trials
  • Patients unable to provide informed consent
  • Patients with active infections or sepsis (serious infection affecting the whole body)
  • Patients with history of abdominal surgery in the past 3 months
  • Patients with portal vein thrombosis (blood clot in the main blood vessel of the liver)
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Investigated drugs

VS-01 is a medication administered intraperitoneally (directly into the abdominal cavity) in addition to standard care treatment. It is being studied for treating hepatic encephalopathy, a condition that affects brain function in people with liver disease. The medication is given once daily and remains in the abdominal cavity for several hours. Standard of Care (SOC) refers to the currently accepted treatment methods that patients typically receive for hepatic encephalopathy. This includes the usual medications and supportive care that are considered the normal treatment for this condition.

What is already known about the treatment

VS-01 - An investigational medication administered intraperitoneally (directly into the abdominal cavity) with specific dwell times of 3 to 4 hours, used in combination with standard of care treatment. This drug is currently being studied in Phase 2 clinical trials for patients with overt hepatic encephalopathy (brain dysfunction due to liver disease) and liver cirrhosis complications. The medication is being evaluated for its effectiveness in improving brain function in patients with acute liver deterioration, though its exact molecular mechanism of action requires further research through ongoing clinical studies. VS-01 represents a novel therapeutic approach in hepatology, being tested as an add-on therapy to current standard treatments. Note: The provided description is based on available clinical trial information, and since VS-01 is an investigational drug, some details about its pharmacological classification and complete mechanism of action are not yet publicly established.

Investigated diseases

  • Hepatic Encephalopathy

    A brain condition that occurs when the liver can't remove toxins from the blood effectively. It develops as a complication of liver disease, causing confusion, altered consciousness, and changes in behavior. The condition can progress from mild mental changes to severe disorientation and drowsiness. It commonly occurs in people with cirrhosis when their liver function worsens suddenly.

  • Liver Cirrhosis

    A late-stage liver condition where healthy liver tissue is replaced by scar tissue, disrupting normal liver function. The scarring process happens gradually over time, affecting the liver's ability to process nutrients, hormones, drugs, and toxins. The condition develops slowly, often over years or decades, as the liver tries to repair repeated damage.

  • Acute-on-Chronic Liver Failure

    A sudden deterioration of liver function in a person who already has chronic liver disease. It involves rapid loss of liver function, usually triggered by an acute event or injury. The condition represents a more severe form of liver dysfunction than typical cirrhosis complications.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521029-34-00Protocol codeVS01_P2_24_2Estimated enrolment51 patientsSponsorVersantis AG

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