Overview

Effects of Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites

Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20% administration versus SMT alone in subjects with decompensated cirrhosis and ascites. The study population will consist of subjects being discharged after hospitalization for acute decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy) with or without acute-on-chronic liver failure (ACLF) at admission or during hospitalization but without ACLF at discharge.
Phase:
Phase 3
Details
Lead Sponsor:
Grifols Therapeutics LLC
Collaborator:
Instituto Grifols, S.A.