Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5%

About the trial

Sponsor

Instituto Grifols, S.A.

Tested

SMT + PE-A 5% (biological), Standard Medical Treatment (other)

Dates

Started 2019-06-17; completion 2025-04-14

Results posted

Yes

This is a Phase 3, multicenter, randomized, controlled, parallel-group, open-label study to evaluate the effects of plasma exchange using human serum albumin 5% (PE-A 5%) in acute-on-chronic liver failure (ACLF) subjects. The study will involve approximately 40 study centers in the United States, Canada, and Europe with expertise in the management of subjects with ACLF. Subjects with ACLF at a high risk of hospital mortality will be enrolled. The study will consist of a Screening Period during which subjects will be randomized (1:1) to receive either standard medical treatment (SMT) + PE-A 5% (treatment group) or SMT only (control group), followed by a Treatment Period, and a Follow-up Pe…

From ClinicalTrials.gov, last updated 2026-06-04. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Grifols Therapeutics LLC reported $312,506 in research payments for this study in 2025 (43 payments).

Products named: Albutein

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.