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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Academisch Ziekenhuis Leiden Leiden The Netherlands
University Of Debrecen Debrecen Hungary
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Odense University Hospital Odense Denmark
Westfaelische Wilhelms Universitaet Muenster Munster Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
30.09.2022
Denmark Denmark
Not yet recruiting
30.09.2022
Germany Germany
Not yet recruiting
30.09.2022
Hungary Hungary
Not yet recruiting
30.09.2022
Spain Spain
Not yet recruiting
30.09.2022
The Netherlands The Netherlands
Not yet recruiting
30.09.2022

Trial locations

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.

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 ID:
2022-501006-34-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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