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NCT05900050 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®
A Phase 2 study, sponsored by Genfit.
- Terminated
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT05900050: Clinical Trial Phase 2 study, sponsored by Genfit.
NCT05900050 is a Phase 2 study that was terminated before completion, run by Genfit. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05900050, a Phase 2 study, was terminated before completion, sponsored by Genfit.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
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)
Primary Outcome
The CLIF-C ACLF score is derived from the CLIF-C organ failure (OF) score. The formula for the CLIF-C ACLF score is CLIF-ACLF = 10\*\[0.33\*CLIF-C OF + 0.04\*Age + 0.63\*Ln(white cell count) -2\]. The CLIF-C ACLF score ranges from 0-100, where a higher score indicated a greater mortality risk.
Interventions
- DRUG VS-01 on top of SOC
- OTHER SOC (Control Group)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-07-02 |
| Est. Completion | 2025-10-15 |
| Phase | Phase 2 |
Why NCT05900050 stopped before completion
NCT05900050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which VS-01 on top of SOC is the first listed.
NCT05900050 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05900050 about?
NCT05900050 is a clinical study titled "Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®". 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 Fa...
What is the current status of trial NCT05900050?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2023-07-02. Estimated completion is 2025-10-15.
What interventions are being tested in trial NCT05900050?
The interventions under investigation include: VS-01 on top of SOC (DRUG), SOC (Control Group) (OTHER).
Who is sponsoring clinical trial NCT05900050?
This trial is sponsored by Genfit, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05900050's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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