435 Studies Now Enrolling
A Phase 2a, Open-Label, Randomized, Controlled, Multicenter, 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) Grades 1 and 2 and Ascites
Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)
| Sponsor: | Genfit Versantis AG |
| Enrolling: | Male and Female Patients |
| IRB Number: | AAAV0954 |
| U.S. Govt. ID: | NCT05900050 |
| Contact: | Transplant Clinical Research Center: / tcrcstudyreferral@cumc.columbia.edu |
Additional Study Information:
The purpose of this research study is to determine if an investigational drug, VS-01, will help in the treatment of acute-on-chronic liver failure (ACLF) compared to supportive care (standard of therapy). ACLF is a potentially life-threatening condition characterized by a group of signs that occur together (syndrome) in patients with a late stage of scarring of the liver (cirrhosis). Study participation will begin during a hospitalization, and will last approximately 90 days. Participants will be randomly assigned (like a flip of a coin) to receive either the investigational drug on top of standard therapy or standard therapy alone. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
