VS-01 for Liver Failure and Ascites
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.12345Why 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.13467
Who Is on the Research Team?
Katharina Staufer, MD
Principal Investigator
Versantis AG
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive VS-01 on top of standard of care or standard of care alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
Safety Monitoring
Monitoring of adverse drug reactions and serious adverse drug reactions
What Are the Treatments Tested in This Trial?
Interventions
- VS-01
Find a Clinic Near You
Who Is Running the Clinical Trial?
Versantis AG
Lead Sponsor