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NCT05900050 (VS-01 in Acute-on-Chronic Liver Failure and Ascites): BVCT ex-ante prediction vs. reported outcome

On 14 Feb 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 19 Sep 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05900050
Acronym
UNVEIL-IT
Drug Name
VS-01
Drug MoA
liposomal-based intro-peritoneal fluid
Drug Modality
fluid
Drug Class
First-In-Class
Therapeutic Area
Digestive System Diseases
Indication
Acute-on-Chronic Liver Failure and Ascites
Human Patients
15
Sponsor
Genfit
Phase
Phase 2

Prediction of , index 1468

Prospective Prediction
Prediction Index
1468
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
583 days in advance
Readout Data Interpretation
VS-01’s further development has been discontinued for insufficient benefit/risk profile
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

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)
Phase
Phase 2
Status
Terminated
Enrollment
15
Lead sponsor
Genfit
Conditions
Acute-On-Chronic Liver Failure; Ascites
Interventions
DRUG: VS-01 on top of SOC; OTHER: SOC (Control Group)
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2023-07-02
Primary completion
2025-10-15
Completion
2025-10-15
Results first posted
2026-07-23
Primary outcomes
  • Chronic Liver Failure Consortium (CLIF-C) ACLF Score at Day 7 (Day 7)

NCT05900050 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials