NCT03451292

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 410 (actual)
• Sponsor: Grifols Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Decompensated Cirrhosis and Ascites

Interventions

Type	Name	Description
DRUG	Albutein 20%	Injectable solution
OTHER	SMT	Participants received SMT according to institution standards for the management of decompensated cirrhosis.

Timeline

• Start date: 2018-07-24
• Primary completion: 2024-05-21
• Completion: 2024-05-21
• First posted: 2018-03-01
• Last updated: 2025-06-06
• Results posted: 2025-06-06

Locations

66 sites across 14 countries: United States, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Denmark, France, Germany, Hungary, Italy, Poland, Serbia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study