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Blood filtering treatment tested for sudden liver failure

NCT ID NCT03702920

Disease control Sponsor: Instituto Grifols, S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a blood filtering procedure called plasma exchange using a 5% albumin solution in people with acute-on-chronic liver failure (ACLF), a sudden worsening of chronic liver disease. The trial enrolled 274 high-risk patients across the US, Canada, and Europe, comparing standard medical care plus plasma exchange to standard care alone. The goal was to see if the treatment could reduce deaths within 90 days. However, the study was terminated early, so the results are not conclusive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
plasma exchange with human serum albumin 5% (Albutein 5%)
What this could lead to
If successful, this treatment could improve short-term survival for people with acute-on-chronic liver failure who are at high risk of dying in the hospital.
What could go wrong
The trial was terminated early, so results are limited. The treatment involves risks like infection or bleeding, and it is unclear if it works better than standard care alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

274 people

The number who actually took part.

Started

Jun 2019

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 79 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female cirrhotic subjects between 18 and 79 years of age. * Subjects with ACLF-1b, ACLF-2, or ACLF-3a detected either at admission or during hospitalization (must be ACLF-1b, -2, or -3a within the Screening Period \[a maximum of 10 days\]). * Willing and able to provide written informed consent or have an authorized representative able to provide written informed consent on behalf of the subject in accordance with local law and institutional policy. * In case of HE, informed consent will be provided by a relative or a legally authorized representative if the subject is considered incompetent to consent. Exclusion Criteria: * Subjects without ACLF. * Subjects with ACLF-1a or ACLF-3b after the Screening Period. * Subjects fulfilling inclusion criteria that improve to no ACLF or to ACLF-1a or worsen to ACLF-3b during the Screening Period (between initial evaluation and time of randomization). * Subjects with ACLF for more than 10 days prior to randomization. * Subjects with acute or subacute liver failure without underlying cirrhosis. * Subjects with septic shock requiring use of norepinephrine (\> 0.3 mcg/kg/min) or need for a second vasopressor (including terlipressin). * Subjects with active bacterial or fungal infection: who have received less than 24h of appropriate antibiotic treatment. * Subjects with severe respiratory failure with PaO2/FiO2 ≤200. * Subjects with active or recent bleeding (unless controlled for \>48 hours). * Subjects with severe thrombocytopenia (≤20×10\^9/L) (based on local laboratory assessment). * Subjects with chronic renal failure and currently receiving hemodialysis. * Evidence of current locally advanced or metastatic malignancy. Subjects with hepatocellular carcinoma within the Milan criteria (1 nodule ≤5 cm or 3 nodules ≤3 cm), non-melanocytic skin cancer, and controlled breast or prostate cancer, can be included). * Subjects with severe chronic heart failure (New York Heart Association \[NYHA\] class III or IV). * Subjects with severe pulmonary disease (Global Obstructive Lung Disease \[GOLD\] stage III or IV). * Subjects with severe myopathy as defined clinically. * Subjects with a known infection with human immunodeficiency virus (HIV) or have clinical signs and symptoms consistent with current HIV infection. * Females who are pregnant, breastfeeding, or if of childbearing potential, unwilling to practice a highly effective method of contraception. * Subjects with previous liver transplantation. * Subjects receiving anti-platelet or anti-coagulant therapy (LMWH for DVT prophylaxis is allowed). * Participation in another clinical study within at least 30 days prior to screening. * Subjects with active drug addiction (exceptions: active alcoholism or marijuana). * Subjects with a do-not-resuscitate order. * In the opinion of the investigator, the subject may have compliance problems with the protocol and the procedures of the protocol. * Subjects with current infection of COVID-19, those who are less than 14 days post recovery or those who have clinical signs and symptoms consistent with COVID-19 infection.

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Conditions

The condition(s) this trial relates to.

Acute-On-Chronic Liver Failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute-on-chronic liver failure

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Aurora Health Care, Inc.

    Milwaukee, Wisconsin, 53215, United States

  • Azienda Ospedaliera di Padova

    Padova, 35128, Italy

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I

    Roma, Roma, 161, Italy

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centre Hépato-Biliaire - Hôpital Universitaire Paul Brousse

    Villejuif, 94804, France

  • Centro Hospitalar do Porto

    Porto, Portugal

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Hannover Medical School

    Hanover, 30625, Germany

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario del Valle Hebron

    Barcelona, 08035, Spain

  • Hôpital Beaujon

    Clichy, 92110, France

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS, United Kingdom

  • Klinikum der Universitaet Muenchen

    München, 81377, Germany

  • Mayo Clinic Rochester

    Rochester, New York, 55905, United States

  • McGuire VA Medical Center

    Richmond, Virginia, 23249, United States

  • Medical University of Vienna

    Vienna, A-1090, Austria

  • Milano Hospital Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, Milan, 20122, Italy

  • Nottingham University Hospital

    Nottingham, Nottingham, NG72UH, United Kingdom

  • Royal Free NHS Foundation Trust Hospital

    London, London, NW3 2QG, United Kingdom

  • Rutgers-New Jersey Medical School

    Newark, New Jersey, 07101, United States

  • Southern California Research Center

    Coronado, California, 92118, United States

  • UZ Leuven - Campus Gasthuisberg

    Leuven, 3000, Belgium

  • Universitaetsklinikum Leipzig

    Leipzig, 4103, Germany

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590, Germany

  • Université libre de Bruxelles

    Brussels, 1070, Belgium

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Other studies related to the condition(s) this trial covers.