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Study on the Effects of Human Serum Albumin on Survival in Patients with Severe Acute-On-Chronic Liver Failure

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Acute-On-Chronic Liver Failure (ACLF), which occurs in people who already have liver cirrhosis and then experience a sudden worsening of their liver function. The study is particularly interested in patients with specific stages of this condition, referred to as ACLF-1b, ACLF-2, or ACLF-3a. These stages indicate varying levels of severity in the liver's failure to function properly.

The treatment being tested in this study is called Human Serum Albumin, which is a protein derived from human blood. It is used in a solution form for infusion, meaning it is administered directly into the bloodstream through a vein. The specific product used in this trial is known as Albutein 50 g/l solution for infusion. The study aims to evaluate the effect of combining this treatment with standard medical care to see if it improves the 90-day survival rate of patients with ACLF.

Participants in the study will receive either the standard medical treatment alone or the standard treatment plus the Human Serum Albumin solution. The study will monitor the participants over a period to assess their overall survival and other health outcomes. The goal is to determine if the addition of the albumin solution can help improve the chances of survival for patients with this serious liver condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. Participants are individuals with cirrhosis and specific types of acute-on-chronic liver failure (ACLF-1b, ACLF-2, or ACLF-3a).

    Participants must be between 18 and 79 years old and provide informed consent, either personally or through a representative if unable to do so.

  2. Step 2

    Treatment initiation

    The treatment involves standard medical treatment (SMT) combined with plasma exchange using human serum albumin 5% (PE-A 5%).

    The human serum albumin is administered as a solution for infusion through an intravenous route.

  3. Step 3

    Treatment duration

    The primary goal is to evaluate the effect of the treatment on 90-day overall survival.

    Secondary goals include assessing 90-day transplant-free survival and 28-day overall survival compared to SMT alone.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored throughout the study to assess the effectiveness and safety of the treatment.

    The study is expected to conclude by September 30, 2025.

Who can join the trial?

4 criteria

  • Participants must be **male or female** and between **18 and 79 years old**.
  • Participants must have **cirrhosis** with a condition called **ACLF-1b, ACLF-2, or ACLF-3a**. This condition can be detected either when they are admitted to the hospital or during their stay. It must be confirmed within a **10-day screening period**.
  • Participants must be **willing and able to provide written informed consent**. If they cannot do this themselves, an authorized representative can provide consent on their behalf, following local laws and policies.
  • If a participant has a condition called **hepatic encephalopathy**, which affects the brain due to liver problems, a relative or legally authorized representative must provide consent if the participant is unable to do so.

Who cannot join the trial?

1 criterion

  • Patients with **cirrhosis** who have a condition called **ACLF-1b**, **ACLF-2**, or **ACLF-3a**. Cirrhosis is a liver disease, and ACLF stands for **Acute-on-Chronic Liver Failure**, which is a severe liver condition.
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Investigated drugs

Human Serum Albumin 5% is a solution used in plasma exchange therapy. In this clinical trial, it is being tested to see if it can improve short-term survival in patients with acute-on-chronic liver failure. The therapy involves replacing a portion of the patient's plasma with this albumin solution, which may help in managing the condition and reducing the risk of hospital mortality.

What is already known about the treatment

Human Serum Albumin 5% – This medication is administered intravenously and is used in plasma exchange procedures. It is currently being studied in clinical trials for its potential to improve short-term survival in patients with acute-on-chronic liver failure (ACLF) who are at high risk of hospital mortality. The main therapeutic indication is for subjects with cirrhosis experiencing severe liver failure. At the molecular level, Human Serum Albumin works by maintaining oncotic pressure and transporting various substances in the blood. It is classified pharmacologically as a plasma volume expander.

Investigated diseases

Cirrhosis with Acute-on-Chronic Liver Failure (ACLF) – Cirrhosis is a condition where the liver becomes severely scarred, affecting its ability to function properly. Acute-on-Chronic Liver Failure (ACLF) is a sudden worsening of liver function in individuals with pre-existing liver disease, such as cirrhosis. It is characterized by the rapid development of liver failure and can involve other organs, leading to complications. ACLF is classified into different grades, such as ACLF-1b, ACLF-2, and ACLF-3a, based on the severity and number of organ failures. The progression of ACLF can vary, with some patients experiencing a rapid decline in liver function. The condition requires careful monitoring and management to address the complications that arise.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502187-20-00Protocol codeIG1407Estimated enrolment480 patientsSponsorInstituto Grifols S.A.

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