VS-01 for Liver Failure and Ascites

No longer recruiting at 30 trial locations

Overseen By Katharina Staufer, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Versantis AG

Must not be taking: Steroids, Antivirals, Immunosuppressants, others

Disqualifiers: Respiratory failure, Coagulation failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VS-01 for individuals with liver failure and fluid buildup in the abdomen, known as ascites. The researchers aim to determine if VS-01, combined with standard care, manages liver-related organ problems more effectively than standard care alone. Individuals who have experienced a sudden worsening of their liver condition and require abdominal fluid drainage might be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on antiviral or high-dose steroid treatments for certain conditions, you may not be eligible to participate.

Is there any evidence suggesting that VS-01 is likely to be safe for humans?

Research has shown that VS-01 has been tested for safety in people with liver problems. Studies indicate that this treatment can reduce the need for frequent fluid removal from the abdomen, suggesting it may help manage symptoms in everyday life. Although some technical issues arose, better management successfully reduced them.

The trial under consideration is a Phase 2 study, meaning the treatment has already passed initial safety tests and is now being studied further. Phase 2 trials typically focus on how well patients tolerate the treatment and its effectiveness. So far, no major safety concerns have been reported for VS-01, suggesting it is reasonably well-tolerated. However, like any treatment, side effects may occur, and discussing any concerns with the trial team is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for liver failure and ascites?

Unlike the standard of care for liver failure and ascites, which typically involves diuretics, paracentesis, and albumin infusions, VS-01 is unique because it offers a novel approach by targeting the underlying mechanisms of fluid accumulation. Researchers are excited about VS-01 because it has the potential to improve fluid regulation in the body more effectively than current methods. This new treatment could lead to better management of symptoms and an improved quality of life for patients with decompensated cirrhosis and acute-on-chronic liver failure (ACLF).

What evidence suggests that VS-01 might be an effective treatment for liver failure and ascites?

Research has shown that VS-01, which participants in this trial may receive, may help treat problems related to liver failure and fluid buildup in the abdomen. Studies have found that VS-01 is safe and well tolerated by patients with cirrhosis, a liver disease that can cause these issues. Early evidence suggests that VS-01 might improve symptoms by removing toxins from the body more effectively. This treatment delivers its effects directly into the abdominal area, potentially increasing its effectiveness. Although more research is needed, the initial results are promising for those dealing with sudden worsening of chronic liver failure and fluid buildup. ^{1 3 4 6 7}

Who Is on the Research Team?

Pejvack MOTLAGH, M.D, M.Sc

Principal Investigator

Genfit

Are You a Good Fit for This Trial?

This trial is for adults with liver cirrhosis and acute-on-chronic liver failure (ACLF) grades 1 or 2, who have fluid buildup in the abdomen (ascites). Participants must be diagnosed within the last 96 hours before screening and have a BMI under 35. They need to give written consent before any study procedures begin.

Inclusion Criteria

Written informed consent obtained prior to the start of any study-related procedures

My acute liver failure started less than 96 hours ago.

Patients with body mass index (BMI) < 35 kg/m²

Exclusion Criteria

I am not willing to use birth control.

Alfapump® in place to manage ascites

I had an infection in my abdomen within the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VS-01 on top of standard of care or standard of care alone

12 weeks

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Safety Monitoring

Monitoring of adverse drug reactions and serious adverse drug reactions

90 days

What Are the Treatments Tested in This Trial?

Interventions

• VS-01

Trial Overview

The trial is testing VS-01, a liposomal formulation given into the abdominal cavity, on top of standard care (SOC), compared to SOC alone. It's an open-label study where both doctors and patients know which treatment is being administered.

How Is the Trial Designed?

Group I: VS-01 on top of SOC (Active Treatment Group) Experimental Treatment 1 Intervention

Patients randomized to Active Treatment group will receive VS-01 on top of SOC

Group II: SOC (Control Group) Experimental Treatment 1 Intervention

Patients randomized to Control group will receive SOC defined as the standard medical management of patients with decompensated cirrhosis and ACLF

Who Is Running the Clinical Trial?

Versantis AG

Lead Sponsor

Trials

1

Recruited

60+

Genfit

Lead Sponsor

Trials

20

Recruited

3,500+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05900050

NCT05900050 | Efficacy, Safety and Tolerability of VS-01 ...

Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®. ClinicalTrials.gov ID NCT05900050.

2.

clinicaltrials.eu

clinicaltrials.eu/trial/study-on-the-effects-of-vs-01-for-adults-with-acute-on-chronic-liver-failure-and-ascites/

Study on the Effects of VS-01 for Adults with Acute-on- ...

This clinical trial tests the effectiveness and safety of VS-01, a new treatment for adults with acute-on-chronic liver failure and ascites, ...

3.

mayo.edu

mayo.edu/research/clinical-trials/cls-20570322

Efficacy, Safety And Tolerability Of VS-01 In Adult Patients ...

A Phase 2, multi-center, randomized, controlled, open-label study to evaluate the effects of the intraperitoneal, liposomal formulation VS-01 in patients with ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11737501/

Comparison of clinical outcomes in patients with refractory ...

Overall, mortality, AKI, and hyponatremia were comparable between the ascites pump and PeCa. Data from previous studies also implicate that ...

5.

swissbiotech.org

swissbiotech.org/listing/versantis-showcases-first-clinical-data-of-vs-01-at-the-liver-meeting-2021-by-aasld/

Versantis: First clinical data for treatment of ascites and ...

The data show that VS-01 is safe and well tolerated in cirrhotic patients with ascites and covert (mild) hepatic encephalopathy, so very promising.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35686702/

Final safety and efficacy results from a 106 real-world ...

The device reduced paracentesis frequency in a real-world setting. Technical complications were successfully decreased by optimization of management and ...

7.

ir.genfit.com

ir.genfit.com/news-releases/news-release-details/genfit-announces-discontinuation-its-vs-01-program-aclf-vs-01

VS-01 Development Refocused on UCD | GENFIT

We hope to deliver positive results, as we move forward, starting with safety data and early markers of efficacy on healthy volunteers with ...