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Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5%
Sponsor: Instituto Grifols, S.A.
Summary
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 Period. The Treatment Period for subjects in the SMT+ PE-A 5% treatment group will be between 7 and 17 days, depending on ACLF evolution. The Treatment Period for subjects in the SMT control group will be a minimum of 7 days for all subjects and up to 17 days depending on the ACLF evolution. Subjects in this group will receive SMT according to the institution's standards. The Follow-up Period for subjects in both groups will be 90 days.
Official title: Effects of Plasma Exchange With Human Serum Albumin 5% (PE-A 5%) on Short-term Survival in Subjects With "Acute-On-Chronic Liver Failure" (ACLF) at High Risk of Hospital Mortality
Key Details
Gender
All
Age Range
18 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
274
Start Date
2019-06-17
Completion Date
2025-04-14
Last Updated
2026-06-04
Healthy Volunteers
No
Conditions
Interventions
SMT + PE-A 5%
Plasma exchange treatment (PE-A 5%) will be performed using 5% albumin solution (Albutein 5%). Fresh frozen plasma will be given to prevent coagulopathy. IVIGs will be administered intravenously to prevent the development of hypogammaglobulinemia and infection. SMT in addition to PE-A 5% according to the institution's standard practice.
Standard Medical Treatment
Standard medical treatment according to the institution's standard practice
Locations (30)
Southern California Research Center
Coronado, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Emory University
Atlanta, Georgia, United States
Rutgers-New Jersey Medical School
Newark, New Jersey, United States
Mayo Clinic Rochester
Rochester, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
McGuire VA Medical Center
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Aurora Health Care, Inc.
Milwaukee, Wisconsin, United States
Medical University of Vienna
Vienna, Austria
Université libre de Bruxelles
Brussels, Belgium
UZ Leuven - Campus Gasthuisberg
Leuven, Belgium
Hôpital Beaujon
Clichy, France
Centre Hépato-Biliaire - Hôpital Universitaire Paul Brousse
Villejuif, France
Universitätsklinikum Frankfurt
Frankfurt, Germany
Hannover Medical School
Hanover, Germany
Universitaetsklinikum Leipzig
Leipzig, Germany
Klinikum der Universitaet Muenchen
München, Germany
Milano Hospital Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Milan, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Roma, Roma, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Azienda Ospedaliera di Padova
Padova, Italy
Centro Hospitalar do Porto
Porto, Portugal
Hospital Universitario del Valle Hebron
Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Royal Free NHS Foundation Trust Hospital
London, London, United Kingdom
Nottingham University Hospital
Nottingham, Nottingham, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom