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

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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 is severely scarred and its function is impaired. The study specifically targets patients who have developed complications such as fluid buildup in the abdomen, known as ascites. The treatment being tested is Human Albumin Grifols 200 g/l, solution for infusion, which is a protein derived from human blood that can help maintain blood volume and support liver function. Another substance used in the study is sodium chloride, commonly known as salt, which is used in a solution for infusion.

The purpose of the study is to validate a predictive biomarker, which is a biological indicator that can help predict how well a patient will respond to the human albumin therapy. The study will involve administering the treatment through an intravenous infusion, which means the solution is delivered directly into the bloodstream through a vein. Participants will receive the treatment over a period of time, and their health will be monitored to observe any changes or improvements in their condition.

Throughout the study, researchers will track various health outcomes, such as the number of liver-related complications, survival rates, and quality of life. They will also monitor any side effects or adverse reactions to the treatment. The study aims to provide valuable insights into the effectiveness of human albumin therapy for patients with liver cirrhosis and ascites, potentially leading to improved treatment strategies in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the study, eligibility is confirmed based on specific criteria. These include having decompensated liver cirrhosis with a Child-Pugh score between 7 and 12, evidence of ascites (fluid in the abdomen), being 18 years or older, and having at least five days since any recent hospitalization or decompensation event.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to gather baseline health information. This may include physical examinations, blood tests, and imaging studies to evaluate liver function and overall health status.

  3. Step 3

    Treatment phase

    The treatment involves receiving human albumin through an intravenous infusion. This is a solution administered directly into the bloodstream. The specific dosage and frequency are personalized based on individual needs and responses to the treatment.

    Additionally, sodium chloride solution may be administered as part of the infusion process to maintain fluid balance.

  4. Step 4

    Monitoring

    Regular monitoring is conducted to assess the response to treatment. This includes tracking liver-related clinical outcomes such as variceal bleeding, ascites, infections, kidney function, and mental status changes.

    Blood tests and other assessments are performed periodically to evaluate changes in serum albumin levels and overall health.

  5. Step 5

    Follow-up visits

    Scheduled follow-up visits are required to review progress and adjust treatment as necessary. These visits may include physical examinations, discussions about any side effects, and additional tests to monitor liver function and other health parameters.

  6. Step 6

    Completion

    The trial is expected to continue until March 31, 2025. Upon completion, a final assessment is conducted to evaluate the overall impact of the treatment on liver health and quality of life.

    Participants may be asked to provide feedback on their experience and any changes in their health status during the trial.

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 health event or any condition that required a hospital stay.

Who cannot join the trial?

6 criteria

  • Patients with **liver cirrhosis** cannot participate. This is a condition where the liver is severely damaged and scarred.
  • Patients with **ascites** cannot participate. This is a condition where fluid builds up in the abdomen.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are not part of the specified clinical trial groups cannot participate. The study is designed for specific groups of patients.
  • Patients who are not male or female cannot participate. The study includes both male and female participants.
  • Patients who are considered part of a vulnerable population cannot participate. This includes individuals who may need special protection or care.
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Investigated drugs

Human Albumin is a protein that is naturally found in your blood. In this trial, it is used as a treatment for patients with cirrhosis and ascites, which are conditions related to liver disease. The therapy aims to help manage fluid buildup in the body and improve overall health by maintaining the right balance of fluids in the blood vessels. The trial is also looking to see if certain markers in the body can predict how well a patient will respond to this treatment.

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, 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 pharmacologically as a plasma expander, 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 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 may result in severe complications that require medical intervention.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501006-34-01Estimated 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).