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Virus Therapy

VS-01 on top of SOC (Active Treatment Group) for Liver Failure

Phase 2

Recruiting

Research Sponsored by Versantis AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of ascites requiring paracentesis

Cirrhotic patients with ACLF Grade 1 or 2 according to European Association for the Study of the Liver (EASL)-CLIF criteria as described in the EASL-Clinical Practice Guideline on decompensated liver cirrhosis (EASL Clinical Practice Guidelines, 2018)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through days 28 and 90, at day 28 and 90

Awards & highlights

Study Summary

This trial is testing a new treatment called VS-01 in patients with liver cirrhosis who are experiencing organ dysfunctions and accumulation of fluid in their abdomen.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed here, treatments like VS-01 could potentially cause abdominal pain or discomfort, infection risk at injection site, allergic reactions, or impact organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need a procedure to remove excess fluid from my abdomen.

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I have severe liver disease but not the most critical form.

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I have been diagnosed with cirrhosis through clinical assessment, imaging, or tissue analysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through days 28 and 90, at day 28 and 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through days 28 and 90, at day 28 and 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through days 28 and 90, at day 28 and 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Chronic Liver Failure Consortium (CLIF-C) ACLF score at Day 7

Secondary outcome measures

28-day and 90-day mortality

Change in ACLF grade through/at Days 7 and 28

Incidence rate, severity, and relationship to VS-01 of adverse drug reactions and serious adverse drug reactions.

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: VS-01 on top of SOC (Active Treatment Group)Experimental Treatment1 Intervention

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

Group II: SOC (Control Group)Experimental Treatment1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Versantis AGLead Sponsor

Katharina Staufer, MDStudy DirectorVersantis AG

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase still ongoing for participants in this medical study?

"As per the details on clinicaltrials.gov, this medical study is presently seeking eligible candidates. The trial was originally uploaded on July 2nd, 2023 and most recently revised on February 28th, 2024."

Answered by AI

Can individuals younger than 40 years old participate in this medical study?

"Individuals aged 18 to 69 years are eligible for inclusion in this research study."

Answered by AI

At how many different facilities is this research study currently being administered?

"Enrollment for this study is ongoing at 13 sites, including Hannover, Muenster, and Jena. It is advisable to choose a site near you to reduce travel requirements if you decide to participate."

Answered by AI

What is the current number of participants being admitted to this clinical study?

"The trial necessitates the enrollment of 60 eligible participants. Versantis AG, the sponsor, will manage operations at various locations such as Medizinische Hochschule Hannover in Hannover, Nordrhein-Westfalen and Universitatsklinikum Munster in Muenster, Thüringen."

Answered by AI

What is the safety profile of VS-01 in patients receiving standard-of-care treatment as compared to those not receiving it?

"Based on our assessment at Power, we rate the safety of VS-01 in addition to standard-of-care (Active Treatment Group) as a 2 on a scale from 1 to 3. This evaluation is derived from it being a Phase 2 trial with existing safety data but lacking efficacy evidence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)™

2023. "Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)™". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05900050.