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TERMINATED
NCT03702920
PHASE3

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

Sponsor: Instituto Grifols, S.A.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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.

OTHER

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