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Study on the Safety of Human Serum Albumin and Enoxaparin in Patients with Decompensated Cirrhosis at High Risk of Poor Outcome

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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 treatment for patients with decompensated cirrhosis, a severe liver condition where the liver is unable to function properly. The trial will use a combination of two treatments: human serum albumin and enoxaparin sodium. Human serum albumin is a protein found in blood plasma that helps maintain blood volume and pressure, while enoxaparin sodium is a medication that helps prevent blood clots.

The purpose of the study is to evaluate the safety and tolerability of this combination therapy in patients who are at high risk of poor outcomes due to their liver condition. Participants in the study will receive these treatments over a period of up to 90 days. The study will monitor for any side effects, such as pulmonary edema (fluid in the lungs), major bleeding, or thrombocytopenia (a condition where there is a low number of platelets in the blood, which can lead to bleeding).

Throughout the study, researchers will also track changes in the participants' health, including their liver function, kidney function, and overall survival without the need for a liver transplant. The study aims to provide valuable information on whether this combination therapy can improve outcomes for patients with decompensated cirrhosis.

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 trial

    Upon joining the trial, eligibility is confirmed based on specific criteria such as age between 18 and 80 years and having decompensated cirrhosis. The condition should meet certain medical criteria, and recovery from acute decompensation is expected within 72 hours.

  2. Step 2

    Initial treatment phase

    The treatment involves two medications: enoxaparin sodium and human serum albumin. Enoxaparin sodium is administered as a subcutaneous injection, which means it is injected under the skin. Human serum albumin is given through an infusion, which is a slow introduction of the solution into the bloodstream.

    The specific dosage for enoxaparin sodium is 40 mg, and it is provided in a pre-filled syringe. The human serum albumin is administered as a solution with a concentration of 200 g/l.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, regular monitoring is conducted to assess safety and tolerability. This includes checking for any treatment-emergent adverse events such as pulmonary edema, major bleeding, or low platelet count.

    The trial also tracks changes in health status over 90 and 180 days, including hospital readmissions, survival rates, and any complications related to cirrhosis.

  4. Step 4

    Completion of trial

    The trial is expected to conclude by July 22, 2025. Participants will have contributed valuable information regarding the safety and effectiveness of the treatment for decompensated cirrhosis.

Who can join the trial?

4 criteria

  • Age between 18 and 80 years.
  • Patients with decompensated cirrhosis admitted to the hospital due to acute decompensation (AD). This means a sudden worsening of liver function, which can include symptoms like rapid buildup of fluid in the abdomen (ascites), confusion due to liver problems (hepatic encephalopathy), bleeding in the digestive system related to high blood pressure in the liver (portal hypertensive-related gastrointestinal bleeding), bacterial infection, or any combination of these.
  • CLIF-C AD score of 50 or higher at admission or at any time during the hospital stay. This is a score used to assess the severity of liver disease.
  • Recovery from acute decompensation (AD) and expected to be discharged from the hospital within the next 72 hours.

Who cannot join the trial?

4 criteria

  • Patients with **cirrhosis** cannot participate. Cirrhosis is a condition where the liver is severely damaged and scarred.
  • Patients who have experienced **pulmonary edema** are excluded. Pulmonary edema is a condition where fluid builds up in the lungs, making it hard to breathe.
  • Patients with a history of **major bleeding** are not eligible. Major bleeding refers to severe bleeding that can be life-threatening or require medical intervention.
  • Patients with **thrombocytopenia** are excluded. Thrombocytopenia is a condition where there are not enough platelets in the blood, which can lead to excessive bleeding.
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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 therapy to help manage patients with decompensated cirrhosis, a severe liver condition. Albumin can help maintain the right amount of fluid in your blood vessels, which is important for patients with liver problems. It may also help improve circulation and reduce complications related to liver disease.

  • Enoxaparin

    is a medication that helps prevent blood clots. It is often used in patients who are at risk of developing clots due to various health conditions. In this trial, enoxaparin is combined with human albumin to see if it can help improve outcomes for patients with decompensated cirrhosis. By preventing clots, enoxaparin may help reduce the risk of complications such as pulmonary edema, major bleeding, or low platelet counts, which are being monitored in the study.

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 potential benefits in treating patients with decompensated cirrhosis, a severe liver condition. The main therapeutic use of human albumin in this context is to help manage complications associated with cirrhosis. At the molecular level, albumin works by maintaining the right balance of fluids in the blood vessels and tissues, which can help reduce swelling and improve circulation. It is classified as a plasma expander in pharmacology.

  • Enoxaparin

    Enoxaparin is administered subcutaneously, which means it is injected under the skin. It is being evaluated in clinical trials for its role in treating patients with decompensated cirrhosis, particularly those at high risk of poor outcomes. The primary therapeutic indication for enoxaparin in this setting is to prevent blood clots, which can be a complication of cirrhosis. On a molecular level, enoxaparin works by inhibiting certain factors in the blood that are responsible for clotting, thus reducing the risk of clot formation. It is classified as an anticoagulant in pharmacology.

Investigated diseases

Cirrhosis – Cirrhosis is a chronic liver disease characterized by the replacement of healthy liver tissue with scar tissue, which impairs the liver's ability to function properly. This scarring is often the result of long-term damage from conditions such as hepatitis or chronic alcohol abuse. As cirrhosis progresses, the liver becomes increasingly unable to perform vital functions, including detoxifying the blood, producing proteins for blood clotting, and regulating nutrients. Symptoms may include fatigue, weakness, jaundice, and fluid accumulation in the abdomen. Over time, complications such as portal hypertension, hepatic encephalopathy, and increased risk of infections can develop. The progression of cirrhosis can lead to significant liver dysfunction and other systemic issues.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507073-18-00Protocol codeCOMBATEstimated enrolment90 patientsSponsorEuropean Foundation For The Study Of Chronic Liver Failure

sourced from the EU Clinical Trials Register and site verification

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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).