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 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.

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 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 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 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 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 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 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 health event or any condition that required a hospital stay.

Who Cannot Join the Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
University Hospital Jena KöR	Jena	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
F D Roosevelt University General Hospital Of Banska Bystrica	Banska Bystrica	Slovakia
Academisch Ziekenhuis Leiden	Leiden	The Netherlands
Odense University Hospital	Odense	Denmark
University Of Debrecen	Debrecen	Hungary
Univerzitna nemocnica L. Pasteura Kosice	Kosice	Slovakia
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Deutsches Herzzentrum Berlin	Berlin	Germany
Hospital Del Mar	Barcelona	Spain
Alrijne Zorggroep Stichting	Leiderdorp	The Netherlands
Westfaelische Wilhelms Universitaet Muenster	Munster	Germany
Hnqkol Hmrljrmp	Herlev	Denmark

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.01.2023
Denmark	Recruiting	01.01.2023
Germany	Recruiting	01.01.2023
Hungary	Recruiting	01.01.2023
Slovakia	Not yet recruiting	01.01.2023
Spain	Recruiting	01.01.2023
The Netherlands	Recruiting	01.01.2023

Trial locations

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.

Investigated diseases:

Hepatic cirrhosis

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 ID:

2022-501006-34-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?