Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®
| 대상 질환 | Acute-On-Chronic Liver Failure, Ascites |
|---|---|
| 임상 단계 | 2상 |
| 스폰서 | Genfit |
| 상태 | 조기 종료 |
| 참여자 수 | 15 명 |
| 중재(약물) | VS-01 on top of SOC, SOC (Control Group) |
| 시작일 | 2023년 7월 2일 |
| 완료일 | 2025년 10월 15일 |
| 결과 공개일 | 2026년 7월 23일 |
요약
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)
Chronic Liver Failure Consortium (CLIF-C) ACLF Score at Day 7
| Active Treatment Group: VS-01 on Top of SOC | 50.852 ± 15.5459 score on a scale |
|---|---|
| Control Group: SOC Alone | 39.866 ± 6.3557 score on a scale |
BENITIONS에서 보기 ClinicalTrials.gov 원문 보기
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