At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prevention of Mortality With Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites
In Brief
A Phase 3 clinical trial evaluating Albutein 20% and SMT for Decompensated Cirrhosis and Ascites. Completed, enrolled 410 participants across 66 sites in 14 countries.
Detailed 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 participants with decompensated cirrhosis and ascites. The study population will consist of participants 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.
Study Details
Timeline
Interventions
Injectable solution
Participants received SMT according to institution standards for the management of decompensated cirrhosis.