Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®
| 适应症 | Acute-On-Chronic Liver Failure, Ascites |
|---|---|
| 分期 | 2期 |
| 申办方 | Genfit |
| 状态 | 提前终止 |
| 受试者人数 | 15 人 |
| 干预（药物） | VS-01 on top of SOC, SOC (Control Group) |
| 开始日期 | 2023年7月2日 |
| 完成日期 | 2025年10月15日 |
| 结果公布日 | 2026年7月23日 |
摘要
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 |
在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文
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