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

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.

Timeline

Start

2018-07-24

Primary completion

2024-05-21

Completion

2024-05-21

Outcome

Missed primary endpoint

registry NUMBER SMT + Albutein 20%: 33.5 percentage of participants NCT03451292 ↗

registry NUMBER SMT Alone: 38.6 percentage of participants NCT03451292 ↗

registry analysis (superiority test); SMT + Albutein 20% vs SMT Alone; p = 0.17; Hazard Ratio (HR) 0.80 (95% CI 0.58 to 1.10) NCT03451292 ↗

Publications

• Fernandez J, Claria J, Amoros A, Aguilar F, Castro M, Casulleras M, Acevedo J, Duran-Guell M, Nunez L, Costa M, Torres M, Horrillo R, Ruiz-Del-Arbol L, Villanueva C, Prado V, Arteaga M, Trebicka J, Angeli P, Merli M, Alessandria C, Aagaard NK, Soriano G, Durand F, Gerbes A, Gustot T, Welzel TM, Salerno F, Banares R, Vargas V, Albillos A, Silva A, Morales-Ruiz M, Carlos Garcia-Pagan J, Pavesi M, Jalan R, Bernardi M, Moreau R, Paez A, Arroyo V. Effects of Albumin Treatment on Systemic and Portal Hemodynamics and Systemic Inflammation in Patients With Decompensated Cirrhosis. Gastroenterology. 2019 Jul;157(1):149-162. doi: 10.1053/j.gastro.2019.03.021. Epub 2019 Mar 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Albumin	Protein / enzyme biologic	1.5 g/kg	Intravenous

Indications

No indication recorded.