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A Study to See if an Investigational Medicine Called VS-01 Can Help and How Safe it is in the Treatment of Patients with Overt Hepatic Encephalopathy
EU CTIS ID: 2025-521029-34-00
What this study is testing
To evaluate the efficacy of two different dwell times (3 hours and 4 hours) of i.p. VS-01, administered once daily for up to 4 days on top of SOC compared to SOC alone in treating OHE in patients with AD of liver cirrhosis or ACLF grade 1 measured by time to improvement of OHE.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with liver cirrhosis of any underlying etiology (liver cirrhosis diagnosed by standard clinical criteria, imaging findings, and/or histology) who are diagnosed with OHE (according to HEGI) in the presence of: AD (defined as the onset or worsening of ascites, hepatic encephalopathy, gastrointestinal (GI) bleeding, or any combination of them with or without infection); or ACLF grade 1 according to EASL-CLIF criteria;
- Presence of ascites requiring diagnostic or therapeutic paracentesis
- Fasting blood ammonia > upper limit of normal (ULN) at baseline (BL)
- Patients with a dry body weight ≥40 kg and <140 kg
- Male and female patients ≥18 to <80 years of age on the day of signing the informed consent form (ICF)
- Patients willing and able to provide written informed consent. If the patient is not capable of giving consent, or is unable to fully understand or sign the written informed consent based on the Investigator’s judgment, the ICF must be signed by a legally authorized representative (LAR) of the patient in accordance with local regulation
You likely can't join if
- ACLF grade 2 or higher as defined by EASL-CLIF criteria
- Uncontrolled severe infection with hemodynamic instability or shock; patients may be enrolled provided anti-infectives have been administered for at least 48 hours prior to BL with an appropriate response as assessed by the PI
- Need for renal replacement therapy (RRT) or any extracorporeal liver support device
- Any significant disease considered to be potentially detrimental or would preclude the patient from participating in and completing the study as assessed by the PI. This includes but is not limited to hepatocellular carcinoma outside Milan criteria, cholangiocarcinoma, extrahepatic cancer over the past 2 years, or people who inject drugs
- Individuals for whom the PI deems that study participation would be unsafe or not in the interest of the patient
- Pregnancy or lactation
See the full eligibility criteria
Who can join
- Patients with liver cirrhosis of any underlying etiology (liver cirrhosis diagnosed by standard clinical criteria, imaging findings, and/or histology) who are diagnosed with OHE (according to HEGI) in the presence of: AD (defined as the onset or worsening of ascites, hepatic encephalopathy, gastrointestinal (GI) bleeding, or any combination of them with or without infection); or ACLF grade 1 according to EASL-CLIF criteria;
- Presence of ascites requiring diagnostic or therapeutic paracentesis
- Fasting blood ammonia > upper limit of normal (ULN) at baseline (BL)
- Patients with a dry body weight ≥40 kg and <140 kg
- Male and female patients ≥18 to <80 years of age on the day of signing the informed consent form (ICF)
- Patients willing and able to provide written informed consent. If the patient is not capable of giving consent, or is unable to fully understand or sign the written informed consent based on the Investigator’s judgment, the ICF must be signed by a legally authorized representative (LAR) of the patient in accordance with local regulation
What rules you out
- ACLF grade 2 or higher as defined by EASL-CLIF criteria
- Uncontrolled severe infection with hemodynamic instability or shock; patients may be enrolled provided anti-infectives have been administered for at least 48 hours prior to BL with an appropriate response as assessed by the PI
- Need for renal replacement therapy (RRT) or any extracorporeal liver support device
- Any significant disease considered to be potentially detrimental or would preclude the patient from participating in and completing the study as assessed by the PI. This includes but is not limited to hepatocellular carcinoma outside Milan criteria, cholangiocarcinoma, extrahepatic cancer over the past 2 years, or people who inject drugs
- Individuals for whom the PI deems that study participation would be unsafe or not in the interest of the patient
- Pregnancy or lactation
- Women of childbearing potential and non-sterile male patients who are not willing to use adequate contraception from SCR to 30 days after the final dose of investigational medicinal product (IMP)
- Participation in another interventional clinical trial within 30 days of SCR
- Presence of spontaneous or secondary bacterial peritonitis (i.e., neutrophil counts >250/mm 3 in ascitic fluid)
- Contraindication for paracentesis according to the EASL Clinical Practice Guidelines 2018, and the American Association for the Study of Liver Diseases (AASLD) Guideline on the Treatment of Ascites, Spontaneous Bacterial Peritonitis, and Hepatorenal Syndrome 2021
- Alfapump® in place to manage ascites
- Known hypersensitivity to liposomes, history of mastocytosis, multiple hypersensitivities, or similar diseases known to be associated with an increased risk of allergic/anaphylactoid reactions
- Upper GI bleeding within the last 7 days prior to BL, acute bleeding or bleeding upon paracentesis at SCR or BL
- Poorly controlled seizure disorder
- Respiratory failure requiring invasive mechanical ventilation
- Severe circulatory failure requiring the use of high dose vasopressors (e.g., dopamine >15 µg/kg/min, or epinephrine >0.1 µg/kg/min, or norepinephrine >0.1 µg/kg/min); the use of terlipressin or low-dose norepinephrine to treat hepatorenal syndrome is not an exclusion criterion
The study team makes the final eligibility decision.
Where it's taking place
- Georgia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Georgia; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.