Discover our clinical trials protocols
Study contact
Name: Katharina Staufer, MD
Phone Number: +333 20 16 40 00
Email: clinical@versantis.com
Backup contact
Name: Carol Addy, MD
Phone Number: +333 20 16 40 00
Overview
- Trial Name
UNVEIL-IT
- Targeted Pathology
Acute-On-Chronic Liver Failure
- Type of Trial
Phase II
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).
eligibility
Inclusion (H3)
Patients with liver cirrhosis diagnosed by standard clinical criteria, imaging findings and/or histology with any underlying etiology;
Patients with liver cirrhosis 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 acute-on-chronic liver failure (EASL Clinical Practice Guidelines, 2023);
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;
Method of administration
Intervention/Treatment
Patients randomized to Active Treatment group will receive VS-01 on top of SOC. They will receive VS-01 intraperitoneally on four consecutive days on top of SOC.
Patients randomized to Control group will receive SOC defined as the standard medical management of patients with decompensated cirrhosis and ACLF. They will receive SOC for decompensated cirrhosis and ACLF.
Method of administration 2
Intervention/Treatment
Patients randomized to Active Treatment group will receive VS-01 on top of SOC. They will receive VS-01 intraperitoneally on four consecutive days on top of SOC.
Patients randomized to Active Treatment group will receive VS-01 on top of SOC. They will receive VS-01 intraperitoneally on four consecutive days on top of SOC.
Patients randomized to Active Treatment group will receive VS-01 on top of SOC. They will receive VS-01 intraperitoneally on four consecutive days on top of SOC.
Patients randomized to Active Treatment group will receive VS-01 on top of SOC. They will receive VS-01 intraperitoneally on four consecutive days on top of SOC.
Patients randomized to Active Treatment group will receive VS-01 on top of SOC. They will receive VS-01 intraperitoneally on four consecutive days on top of SOC.
Patients randomized to Active Treatment group will receive VS-01 on top of SOC. They will receive VS-01 intraperitoneally on four consecutive days on top of SOC.
Patients randomized to Active Treatment group will receive VS-01 on top of SOC. They will receive VS-01 intraperitoneally on four consecutive days on top of SOC.
Study duration
Study duration and recruitment
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.
Patent 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.
✔️ Voluntary Participation
Enrollment in a clinical trial is entirely voluntary, and participants can withdraw at any time without consequences for their medical care.
✔️ Voluntary Participation
Enrollment in a clinical trial is entirely voluntary, and participants can withdraw at any time without consequences for their medical care.
For more information, visit the World Health Organization (WHO) guide on clinical trials.