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 study about?

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.

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Universitaetsklinikum Aachen AöR	Aachen	Germany
Hopital Beaujon	Clichy	France
Atngkpg Ojaixmbyqpb Ubicfqlqwydmd Ccspiiglhyrn Dqzdf Skutdg E Druhp Scjcfji Dy Tnxnmq	Turin	Italy
Usvrdyqaaqjvftvlltwet Mekoquxd Avl	Munster	Germany
Afpmijr Uddec Stxdgakry Lhgwtt Dd Bqxggho	Bologna	Italy
Hgnvfmfr Vouq dhdjwjqv	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	22.01.2024
Germany	Recruiting	22.01.2024
Italy	Recruiting	22.01.2024
Spain	Recruiting	22.01.2024

Trial locations

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.

Investigated diseases:

Hepatic cirrhosis

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 ID:

2023-507073-18-00

Protocol code:

COMBAT

NCT ID:

NCT05895136

Trial Phase:

Therapeutic exploratory (Phase II)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?