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A clinical study to evaluate a new medicinal product VS-01 in patients with an acute episode on top of a chronic liver disease (called acute-on-chronic liver failure) who experience accumulation of fluid in the abdominal cavity (called ascites) as well as intellectual, behavioral decay and physical decay
EU CTIS ID: 2024-513706-56-00
What this study is testing
To evaluate the efficacy of VS-01 administered intraperitoneally (i.p.) daily over 4 days on top of standard of care (SOC) vs. SOC alone in patients with ACLF grades 1, 2 or 3a as measured by Chronic Liver Failure Consortium Acute on-Chronic Liver Failure (CLIF-C ACLF) score at Day 7
- 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
- 1. Patients with ACLF Grade 1, 2 or 3a according to EASL-CLIF criteria (organ failures will be calculated based on the CLIF-C OF score) in the presence of liver cirrhosis of any underlying etiology
- 2. Onset of ACLF not more than 14 days before BL;
- 3. Presence of ascites requiring diagnostic or therapeutic paracentesis;
- 4. Patients with a dry body weight ≥ 40 kg and < 140 kg;
- 5. Men and women ≥ 18 and ≤ 79 years of age on the day of signing Patient Informed Consent Document (PICD);
- 6. Informed consent: a. Ability to understand the PICD and comply with the protocol and sign the PICD or a legal representative can sign the PICD on behalf of the patient in accordance with local law and institutional policy; b. Signed and dated PICD obtained prior to performing any study-related procedure including SCR.
You likely can't join if
- 1. Presence of any of the following organ failure(s) as per the EASL-CLIF criteria and/or adapted from CLIF-COF/CLIF-SOFA scores: a. Respiratory failure mechanical ventilation; b. Coagulation failure with an INR > 3.2 or platelet count ≤ 20 x 10^9/L; c. Severe cardiovascular failure requiring the use of high doses of 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 in case of hepatorenal syndrome [HRS] is not an exclusion criterion; d. HE West Haven grade 4;
- 10. Potential or known risk factors for allergic/anaphylactoid like reactions (e.g., mastocytosis/elevated basal tryptase) or multiple hypersensitivities;
- 11. Patients after organ transplantation receiving immunosuppressive medication;
- 12. Any severe disease considered to be potentially detrimental at the discretion of the PI. This includes but is not limited to hepatocellular carcinoma (HCC) outside Milan criteria, cholangiocarcinoma, extrahepatic cancer over the past 2 years, or people who inject drugs ;
- 13. Need for RRT or any extracorporeal liver support device (e.g., MARS® , Prometheus® , Plasmapheresis);
- 14. Alfapump® in place to manage ascites;
See the full eligibility criteria
Who can join
- 1. Patients with ACLF Grade 1, 2 or 3a according to EASL-CLIF criteria (organ failures will be calculated based on the CLIF-C OF score) in the presence of liver cirrhosis of any underlying etiology
- 2. Onset of ACLF not more than 14 days before BL;
- 3. Presence of ascites requiring diagnostic or therapeutic paracentesis;
- 4. Patients with a dry body weight ≥ 40 kg and < 140 kg;
- 5. Men and women ≥ 18 and ≤ 79 years of age on the day of signing Patient Informed Consent Document (PICD);
- 6. Informed consent: a. Ability to understand the PICD and comply with the protocol and sign the PICD or a legal representative can sign the PICD on behalf of the patient in accordance with local law and institutional policy; b. Signed and dated PICD obtained prior to performing any study-related procedure including SCR.
What rules you out
- 1. Presence of any of the following organ failure(s) as per the EASL-CLIF criteria and/or adapted from CLIF-COF/CLIF-SOFA scores: a. Respiratory failure mechanical ventilation; b. Coagulation failure with an INR > 3.2 or platelet count ≤ 20 x 10^9/L; c. Severe cardiovascular failure requiring the use of high doses of 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 in case of hepatorenal syndrome [HRS] is not an exclusion criterion; d. HE West Haven grade 4;
- 10. Potential or known risk factors for allergic/anaphylactoid like reactions (e.g., mastocytosis/elevated basal tryptase) or multiple hypersensitivities;
- 11. Patients after organ transplantation receiving immunosuppressive medication;
- 12. Any severe disease considered to be potentially detrimental at the discretion of the PI. This includes but is not limited to hepatocellular carcinoma (HCC) outside Milan criteria, cholangiocarcinoma, extrahepatic cancer over the past 2 years, or people who inject drugs ;
- 13. Need for RRT or any extracorporeal liver support device (e.g., MARS® , Prometheus® , Plasmapheresis);
- 14. Alfapump® in place to manage ascites;
- 15. Pregnancy and lactation;
- 16. Women of child-bearing potential who are not willing to use adequate contraception;
- 17. Patients who participate in another clinical trial at the time of SCR or within 4 weeks prior to SCR.
- AND FRANCE ONLY: 18. Patients who lack social security affiliation.
- 2. ACLF grade 3b: Presence of four or more organ failures according to EASL-CLIF criteria (organ failures will be calculated based on CLIF-C OF score);
- 3. Presence of spontaneous or secondary bacterial peritonitis (i.e., neutrophil counts > 250/mm3 in ascitic fluid);
- 4. Presence of uncontrolled severe infection with hemodynamic instability or shock; patients may be enrolled provided anti-infectives have been administered for at least 48 h before BL with an appropriate response prior to randomization
- 5. Patients with poorly controlled seizure disorder;
- 6. Patients with medical history of gastro-intestinal bleeding over the past 7 days prior to BL, acute bleeding or bleeding upon paracentesis at SCR or BL;
- 7. Contraindication for paracentesis according to the EASL Clinical Practice Guidelines 2018 and AASLD guideline on the treatment of ascites, spontaneous bacterial peritonitis and HRS-AKI for the management of patients with decompensated cirrhosis;
- 8. Coagulation disorders such as disseminated intravascular coagulation (DIC) or hemophilia;
- 9. Potential or known hypersensitivity to liposomes;
The study team makes the final eligibility decision.
Where it's taking place
- 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 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.