Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®
| Заболевание | Acute-On-Chronic Liver Failure, Ascites |
|---|---|
| Фаза | Фаза 2 |
| Спонсор | Genfit |
| Статус | Прекращено |
| Участники | 15 участн. |
| Вмешательство | VS-01 on top of SOC, SOC (Control Group) |
| Дата начала | 2.07.2023 |
| Дата завершения | 15.10.2025 |
| Публикация результатов | 23.07.2026 |
Кратко
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 |
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