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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Katholieke Universiteit te Leuven Leuven Belgium
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Hospital Clinic De Barcelona Barcelona Spain
Hopital Beaujon Clichy France
University Childrens Hospital Queen Fabiola Brussels Belgium
Ukwqfijmyligyeoxqwjhd Mtbvibkk Agy Munster Germany
Culfrh Hpjrbslzjps Rroqkrii Dtymljrnglsilm Angers France
Hpppawkr Uqerabepitngtw Semlmpirlk &auvxxj Hmdpixs dw Hklawadikqf STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
06.09.2025
France France
Not recruiting
06.09.2025
Germany Germany
Not recruiting
06.09.2025
Spain Spain
Not recruiting
06.09.2025

Trial locations

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.

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 ID:
2025-521029-34-00
Protocol code:
VS01_P2_24_2
Trial Phase:
Therapeutic exploratory (Phase II)

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