TERMINATED

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

Conditions

Acute-On-Chronic Liver Failure Ascites Chronic liver diseases Hepatic Dysfunction Extrahepatic Organ Dysfunction Liver Failure Renal Disease Hepatic Impairment Renal Impairment Hepatic Decompensation Cirrhosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

A Phase 2a, Open-label, Randomized, Controlled, Multi-center Proof of Concept Study to Assess the Efficacy, Safety, and Tolerability of VS-01 on Top of Standard of Care, Compared to Standard of Care Alone, in Adult Patients With Acute-on-chronic Liver Failure (ACLF)

Quick Facts

Study Start:2023-07-02

Study Completion:2025-10-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05900050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 79 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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 ≥40 and \<140 kg; 5. Written informed consent obtained prior to the start of any study-related procedures.	1. 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 ≤20 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 peritonitis; 4. Presence of uncontrolled severe infection(with hemodynamic instability or shock); 5. Poorly controlled seizure disorder; 6. Patients with history of upper gastro-intestinal bleeding over the past 7 days prior to BL, acute bleeding or bleeding upon paracentesis at screening (SCR) or BL; 7. Contraindication for paracentesis; 8. Coagulation disorders such as disseminated intravascular coagulation or hemophilia; 9. Potential or known hypersensitivity to liposomes; 10. Potential or known risk factors for allergic/anaphylactoid like reactions (e.g., mastocytosis/elevated basal tryptase) or multiple hypersensitivities; 11. Patients after organ transplantation receiving immunosuppressive medication; 12. 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; 13. Need for Renal Replacement Therapy or any extracorporeal liver support device (e.g., MARS®, Prometheus®, plasmapheresis); 14. Alfapump® in place to manage ascites; 15. Pregnancy and lactation; 16. Women of child-bearing potential who are not willing to use adequate contraception; 17. Patients who participate in another clinical trial at the time of SCR or within 4 weeks prior to SCR.

Inclusion Criteria

Exclusion Criteria

1. 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 ≥40 and \<140 kg;
5. Written informed consent obtained prior to the start of any study-related procedures.

1. 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 ≤20 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 peritonitis;
4. Presence of uncontrolled severe infection(with hemodynamic instability or shock);
5. Poorly controlled seizure disorder;
6. Patients with history of upper gastro-intestinal bleeding over the past 7 days prior to BL, acute bleeding or bleeding upon paracentesis at screening (SCR) or BL;
7. Contraindication for paracentesis;
8. Coagulation disorders such as disseminated intravascular coagulation or hemophilia;
9. Potential or known hypersensitivity to liposomes;
10. Potential or known risk factors for allergic/anaphylactoid like reactions (e.g., mastocytosis/elevated basal tryptase) or multiple hypersensitivities;
11. Patients after organ transplantation receiving immunosuppressive medication;
12. 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;
13. Need for Renal Replacement Therapy or any extracorporeal liver support device (e.g., MARS®, Prometheus®, plasmapheresis);
14. Alfapump® in place to manage ascites;
15. Pregnancy and lactation;
16. Women of child-bearing potential who are not willing to use adequate contraception;
17. Patients who participate in another clinical trial at the time of SCR or within 4 weeks prior to SCR.

Contacts and Locations

Principal Investigator

Katharina Staufer, MD

STUDY_DIRECTOR

Versantis AG

Study Locations (Sites)

University of California Davis Medical Center

Sacramento, California, 95817

United States

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007

United States

Tampa General Hospital

Tampa, Florida, 33606

United States

Piedmont Atlanta Hospital

Atlanta, Georgia, 30309

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

University of Missouri Health Care

Columbia, Missouri, 65212

United States

Columbia University Medical Center/ New York Presbyterian Hospital

New York, New York, 10032

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

The Liver Institute at Methodist Dallas

Dallas, Texas, 75203

United States

Baylor Clinic

Houston, Texas, 77030

United States

Richmond VA Medical Center

Richmond, Virginia, 23249

United States

Virginia Commonwealth University

Richmond, Virginia, 23298

United States

Collaborators and Investigators

Sponsor: Versantis AG

Katharina Staufer, MD, STUDY_DIRECTOR, Versantis AG

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-02

Study Completion Date2025-10-15

Study Record Updates

Study Start Date2023-07-02

Study Completion Date2025-10-15

Terms related to this study

Keywords Provided by Researchers

Chronic liver diseases
Hepatic Dysfunction
Extrahepatic Organ Dysfunction
Liver Failure
Renal Disease
Hepatic Impairment
Renal Impairment
Hepatic Decompensation
Cirrhosis

Additional Relevant MeSH Terms

Acute-On-Chronic Liver Failure
Ascites