Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®
| 対象疾患 | Acute-On-Chronic Liver Failure, Ascites |
|---|---|
| 相 | 第2相 |
| スポンサー | Genfit |
| ステータス | 早期終了 |
| 参加者数 | 15 名 |
| 介入（薬剤） | VS-01 on top of SOC, SOC (Control Group) |
| 開始日 | 2023年7月2日 |
| 完了日 | 2025年10月15日 |
| 結果公開日 | 2026年7月23日 |
概要
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 |
BENITIONS で見る ClinicalTrials.gov の原文を見る
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