Discover our clinical trials protocols
Study contact
Name: Katharina Staufer, MD
Backup contact
Name: Carol Addy, MD
CTGog NCT number (NCT05900050)
EU CT number (2024-513706-56-00)
Overview
- Trial Name
UNVEIL-IT®
- Targeted Pathology
Acute-On-Chronic Liver Failure
- Type of Trial
Phase II
This is a Phase 2 study conducted at multiple locations, where participants are randomly assigned to different groups. In this open-label study, both participants and doctors know which treatment is being given. The goal is to determine whether a new medication called VS-01, when combined with the standard of care (the recommended treatments for patients with the same medical condition, based on individual medical needs), can help in the treatment of patients with ACLF compared to those receiving only the standard of care.
Eligibility
Inclusion and Exclusion Criteria for Patients
Inclusion
- Patients with liver cirrhosis diagnosed by standard clinical criteria, imaging findings and/or histology with any underlying etiology;
- Patients with ACLF grade 1, 2, or 3a according to EASL-CLIF criteria
- Onset of ACLF not more than7 days (168 hours) before Baseline;
- Presence of ascites requiring paracentesis;
- Patients with dry body weight ≥ 40 and <140 kg;
- Written informed consent obtained prior to the start of any study-related procedures.
- 18 years to 79 years
- All gender
Exclusion
- Patients with acute or sub-acute liver failure;
- Presence of the following organ(s) failure(s) as per the EASL definitions and/or adapted from CLIF-C Organ Failure (CLIF-C OF)/CLIF- Sequential Organ Failure
Assessment (CLIF-SOFA) scores:
1.Respiratory failure or mechanical ventilation;
2. Coagulation failure (INR > 3.2 or platelet count ≤ 20 x 109/L);
3. Severe cardiovascular failure requiring the use of high dose vasopressors; - ACLF grade 3b: Presence of four or more organ failures according to EASL-CLIF criteria (organ failures will be calculated based on CLIF-C OF score);
- Presence of spontaneous or secondary bacterial peritonitis;
- Presence of spontaneous bacterial pleural empyema;
- Patients with medical history of spontaneous bacterial peritonitis over the past 2 weeks;
- Presence of uncontrolled severe infection at SCR or Baseline (BL);
- Patients with poorly controlled seizure disorder
- Patients with history of upper gastro-intestinal
- bleeding over the past 7 days, acute 10. bleeding or bleeding upon paracentesis at SCR or BL;
Contraindication for paracentesis; - Coagulation disorders such as disseminated intravascular coagulation or hemophilia;
- Potential or known hypersensitivity to liposomes;
- Potential or known risk factors for allergic/anaphylactoid like reactions (e.g., mastocytosis/elevated basal tryptase) or multiple hypersensitivities;
- Patients after organ transplantation receiving immunosuppressive medication;
- Any severe disease considered to be potentially detrimental at the discretion of the Principal Investigator. This includes but is not limited to hepatocellular carcinoma outside Milan criteria, cholangiocarcinoma, extrahepatic cancer over the past 2 years
or people who inject drugs - Need for Renal Replacement Therapy or any extracorporeal liver support device (e.g., MARS®, Prometheus®, plasmapheresis);
- Alfapump® in place to manage ascites;
- Pregnancy and lactation;
- Women of child-bearing potential who are not willing to use adequate contraception;
- Patients who participate in another clinical trial at the time of SCR or within 4 weeks prior to SCR.
Study Status
Study Recruitment status
The UNVEIL-IT® clinical study started July 2nd 2023. Its estimated study completion date is on June 2025, after the enrollment of close to 60 patients.
Patient right
Clinical trials follow strict ethical and regulatory guidelines to ensure participant safety and well-being. Key principles include:
✔️ Voluntary Participation
Enrollment in a clinical trial is entirely voluntary, and participants can withdraw at any time without consequences for their medical care.
✔️ Informed Consent
Before joining a study, participants receive detailed information about its purpose, procedures, potential risks, and benefits, allowing them to make an informed decision.
✔️ Privacy & Data Protection
Personal data is kept confidential and managed according to strict regulations, such as GDPR in Europe and HIPAA in the USA.
✔️ Ongoing Monitoring
Ethics committees and regulatory authorities oversee trials to ensure compliance with safety standards. Any new risks identified during the study must be communicated to participants.
✔️ Medical Support
Participants receive medical oversight throughout the trial, with appropriate care provided in case of adverse effects.
For more information, visit the World Health Organization (WHO) guide on clinical trials.