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Study on Human Serum Albumin and Sodium Chloride for Patients with Liver Cirrhosis and Ascites

Fast replyRegistered 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 the effects of a treatment for patients with liver cirrhosis, a condition where the liver becomes severely scarred and unable to function properly. The study involves the use of Human Albumin Grifols 200 g/l, solution for infusion, which is a treatment administered through an intravenous infusion. Human albumin is a protein derived from human blood that helps maintain blood volume and pressure. The trial also involves the use of Sodium Chloride, commonly known as salt, which is used in medical settings to help maintain fluid balance in the body.

The purpose of this study is to validate a predictive biomarker, which is a biological indicator, to see how well patients with cirrhosis and a condition called ascites respond to human albumin therapy. Ascites is a complication of liver cirrhosis where fluid builds up in the abdomen. The study will observe patients over a period of time to see how the treatment affects their health, focusing on liver-related outcomes such as bleeding, infections, and kidney issues. The study will also look at the overall survival of patients over six months, the number of organ failures, and the quality of life of the participants.

Participants in the study will receive the treatment for a maximum of 26 weeks. During this time, researchers will monitor various health indicators to assess the effectiveness and safety of the treatment. The study aims to provide valuable insights into how personalized treatment with human albumin can benefit patients with liver cirrhosis and its complications, potentially improving their quality of life and health outcomes.

The research process

The trial runs in 5 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, you will be informed about the purpose and procedures involved. This study focuses on a personalized approach to administering human albumin in patients with liver cirrhosis and complications.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying that you have decompensated liver cirrhosis with a Child-Pugh score between 7 and 12, and that you have ascites, which is fluid accumulation in the abdomen.

    Your age must be 18 years or older, and it should be at least five days since any recent hospitalization or decompensation event.

  3. Step 3

    Treatment phase

    During the treatment phase, you will receive human albumin through an intravenous infusion. This means the solution will be administered directly into your bloodstream.

    You will also receive a sodium chloride solution, also through intravenous infusion. The specific dosage and frequency will be determined by the study team based on your individual needs.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, your health will be closely monitored. This includes tracking any liver-related clinical outcomes such as variceal bleeding, ascites, infections, kidney injury, and hepatic encephalopathy.

    Regular follow-up visits will be scheduled to assess your response to the treatment and to ensure your safety.

  5. Step 5

    Completion of the study

    The study is expected to continue until September 30, 2024. Upon completion, your overall health and any changes in your condition will be evaluated.

    The study aims to improve understanding of how personalized human albumin treatment can benefit patients with liver cirrhosis and ascites.

Who can join the trial?

4 criteria

  • Must have decompensated liver cirrhosis, which is a severe stage of liver disease. This is defined by a Child-Pugh score between 7 and 12. The Child-Pugh score is a system used to measure the severity of liver disease.
  • Must have ascites, which is a condition where fluid builds up in the abdomen. This should be confirmed by a doctor or through an ultrasound.
  • Must be 18 years old or older.
  • Must have had at least five days since recovering from a serious liver-related event or any condition that required a hospital stay.

Who cannot join the trial?

3 criteria

  • Patients with **liver cirrhosis** cannot participate. Liver cirrhosis is a condition where the liver is severely damaged and scarred.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important to check if you fall within the eligible age group.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations may include groups like pregnant women, children, or those unable to give consent.
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Investigated drugs

Human Albumin is a protein that is naturally found in your blood. It helps to maintain the right amount of fluid in your blood vessels and tissues. In this clinical trial, human albumin is used as a treatment for patients with decompensated cirrhosis and ascites. The goal is to see if human albumin can help improve the condition of these patients by reducing fluid buildup in the abdomen and improving overall health. The trial also aims to identify which patients are most likely to benefit from this treatment by using a predictive biomarker. This means they are looking for specific signs in the body that can predict how well a patient will respond to human albumin therapy.

What is already known about the treatment

Human Albumin – Human Albumin is administered intravenously, meaning it is given directly into a vein through an injection or infusion. It is currently being studied in clinical trials for its effectiveness in treating patients with liver cirrhosis and ascites, which is a condition where fluid builds up in the abdomen. The main therapeutic use of Human Albumin in this context is to help manage these symptoms and improve patient outcomes. At the molecular level, Human Albumin works by maintaining the right balance of fluids in the blood vessels, which can help reduce swelling and fluid accumulation. It is classified as a plasma expander in pharmacology, which means it helps increase the volume of blood plasma.

Investigated diseases

Liver cirrhosis – Liver cirrhosis is a chronic disease characterized by the replacement of healthy liver tissue with scar tissue, which impairs liver function. This scarring is often the result of long-term damage from conditions such as hepatitis or chronic alcohol abuse. As the disease progresses, the liver becomes increasingly unable to perform its vital functions, leading to complications like fluid accumulation in the abdomen (ascites), bleeding from enlarged veins in the esophagus (variceal bleeding), and infections. Over time, cirrhosis can also lead to kidney dysfunction and mental confusion due to the buildup of toxins in the blood. The progression of cirrhosis can vary, but it generally leads to a gradual decline in liver function. Advanced stages of the disease may result in liver failure, necessitating liver transplantation.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501006-34-00Estimated enrolment240 patientsSponsorEuropean Foundation For The Study Of Chronic Liver Failure

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).