Purpose

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)

Conditions

Eligibility

Eligible Ages
Between 18 Years and 79 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion 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.

Exclusion Criteria

  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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VS-01 on top of SOC (Active Treatment Group)
Patients randomized to Active Treatment group will receive VS-01 on top of SOC
  • Drug: VS-01 on top of SOC
    Patients will receive VS-01 intraperitoneally on four consecutive days on top of SOC
Other
SOC (Control Group)
Patients randomized to Control group will receive SOC defined as the standard medical management of patients with decompensated cirrhosis and ACLF
  • Other: SOC (Control Group)
    Patients will receive SOC for decompensated cirrhosis and ACLF

Recruiting Locations

Medstar Georgetown University Hospital
Washington, District of Columbia 20007

More Details

Status
Recruiting
Sponsor
Versantis AG

Study Contact

Katharina Staufer, MD
+333 20 16 40 00
clinical@versantis.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.