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

Sponsored by Versantis AG

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...

Current Status

Terminated

Auto-verified from ClinicalTrials.gov

Verified Jan 14, 2026

Phase

Clinical Trial

Sponsor

Versantis AG

Enrollment Target

60

Start Date

Jul 2023

๐Ÿ“Š
1 of 60 participants interested
2% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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)

Who Can Participate

Inclusion Criteria

Patients with ACLF Grade 1, 2, or 3a according to European Association for the Study of the Liver (EASL)-CLIF criteria; 2. Onset of ACLF not more than 14 days before Baseline (BL); 3. Presence of ascites requiring diagnostic or therapeutic paracentesis; 4. Patients with dry body weight โ‰ฅ40 and \<140 kg; 5. Written informed consent obtained prior to the start of any study-related procedures.

Exclusion Criteria

Presence of any of the following organ failure(s) as per the EASL-CLIF criteria and/or adapted from CLIF-C Organ Failure (CLIF-C OF)/CLIF- Sequential Organ Failure Assessment (CLIF-SOFA) scores: 1. Respiratory failure necessitating invasive mechanical ventilation; 2. Coagulation failure (INR \> 3.2 or platelet count โ‰ค20 x 109/L); 3. Severe cardiovascular failure requiring the use of high dose vasopressors; 2. ACLF grade 3b: Presence of four or more organ failures as per EASL CLIF criteria; 3. Presence of spontaneous or secondary bacterial pe

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

60 participants

๐ŸŽ‚

Age Range

18 Years - 79 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Versantis AG

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Sacramento

California

Location available
View Sacramento location page
Unknown

Washington D.C.

District of Columbia

Location available
View Washington D.C. location page
Unknown

Tampa

Florida

Location available
View Tampa location page
Unknown

Atlanta

Georgia

Location available
View Atlanta location page
Unknown

Rochester

Minnesota

Location available
View Rochester location page
Unknown

Columbia

Missouri

Location available
View Columbia location page
Unknown

New York

New York

Location available
View New York location page
Unknown

Cleveland

Ohio

Location available
View Cleveland location page
Unknown

Charleston

South Carolina

Location available
View Charleston location page

๐Ÿ“ And 4 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Find More Liver Disease Trials by City

Browse all liver disease clinical trials in these cities โ€” not just this study.

Looking for Liver Failure Treatment in Phoenix?

Join others in Arizona exploring innovative treatment options through clinical research

Liver Failure Treatment Options in Phoenix, Arizona

If you're searching for Liver Failure treatment in Phoenix, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Phoenix, Los Angeles, Sacramento and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Liver Failure. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 60 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Liver Failure?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Liver Failure

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Liver Failure Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05900050. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.