VS-01 for Liver Failure and Ascites

Recruiting at 28 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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

A Phase 2, multi-center, randomized, controlled, open-label study to evaluate the effects of the intraperitoneal, liposomal formulation VS-01 in patients with an acute episode of hepatic and/or extrahepatic organ dysfunctions and failures in the presence of liver cirrhosis (Acute-on-Chronic Liver Failure, ACLF) and accumulation of fluid in the abdominal cavity (ascites)

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.

Research Team

Katharina Staufer, MD

Principal Investigator

Versantis AG

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+