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Study on the Safety and Effectiveness of Human Plasma Proteins and Glutathione for Patients with Decompensated Cirrhosis

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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 safety and effectiveness of a treatment for patients with decompensated cirrhosis, a severe liver condition where the liver is unable to function properly. The study will use a special solution called Albunorm 20%, which contains human plasma proteins with at least 96% albumin, and another solution called RITION Glutatione, which contains a substance known as glutathione. These treatments are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to assess how these treatments affect the concentration of albumin in the blood and to evaluate their safety in patients who need long-term albumin treatment. Participants in the study will receive either the new albumin solution or the standard commercial albumin solution. The study will last for six months, during which time the participants' health will be closely monitored. This includes checking vital signs, laboratory test results, and any side effects that may occur.

Throughout the study, researchers will also look for signs of how well the treatments are working by examining liver and kidney function, as well as other important health indicators. The goal is to determine if the new albumin solution is safe and effective for patients with decompensated cirrhosis, potentially offering a better treatment option for managing this challenging condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of liver cirrhosis and age between 18 and 85 years.
Informed consent is required to participate in the study.
Step 2
Initial assessment
An initial assessment is conducted to evaluate liver and kidney function, including tests for ascites, bilirubin, albumin, and creatinine levels.
Step 3
Treatment administration
The treatment involves the administration of a human albumin solution, known as Albunorm 20%, through an intravenous infusion.
Another solution, RITION Glutatione, is also administered via intravenous infusion.
The frequency and dosage of these infusions are determined by the study protocol and are aimed at maintaining effective albumin concentration.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the safety and efficacy of the treatment over a period of 6 months.
This includes checking vital signs, laboratory parameters, and recording any adverse events or reactions.
Assessments occur at 1, 3, and 6 months to evaluate organ function and treatment impact.
Step 5
Completion of study
The study is expected to conclude by December 31, 2026.
Final evaluations are conducted to determine the overall safety and efficacy of the treatment.

Who can join the trial?

4 criteria

Diagnosis of **liver cirrhosis** of any cause. This means the liver is scarred and not working properly, and it can be identified through medical tests and examinations.
Patients with **ascites**, which is a buildup of fluid in the belly. Specifically, those with grade 2 and 3 ascites, or grade 1 ascites if they are taking certain water pills (diuretics) at specific doses.
Patients of both genders, aged between 18 and 85 years.
Ability to provide **written and autonomous informed consent**, meaning the patient understands the study and agrees to participate willingly.

Who cannot join the trial?

1 criterion

Patients with **decompensated cirrhosis** cannot participate. This is a condition where the liver is severely damaged and cannot function properly.

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Verified sites

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Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy
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Azienda Ospedaliera di Padova
Padua, Italy
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Azienda Unita Sanitaria Locale Di Bologna
Bologna, Italy

Trial locations

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Investigated drugs

reHA Solution
The reHA solution is a specially formulated human albumin solution designed to restore the structural profile of albumin. It is being tested for its effectiveness in increasing albumin concentration in the blood and its safety in patients with decompensated cirrhosis. This solution aims to provide a new option for long-term albumin treatment in these patients.
Standard Commercial HA Solution
The standard commercial HA solution is a commonly used human albumin solution that is currently available for treating patients with decompensated cirrhosis. It serves as the comparison treatment in this trial to evaluate the effectiveness and safety of the reHA solution. This solution is used to maintain adequate albumin levels in the blood, which is important for patients with liver conditions.

What is already known about the treatment

Human Albumin Solution – This medication is administered intravenously and is used to treat patients with decompensated cirrhosis. It is currently being studied in clinical trials to evaluate its safety and effectiveness compared to standard commercial human albumin solutions. The main therapeutic indication is to manage conditions associated with low albumin levels in the blood, particularly in patients requiring long-term albumin treatment. At the molecular level, human albumin works by maintaining oncotic pressure and transporting various substances in the blood. It is classified as a plasma volume expander in pharmacology.

Investigated diseases

Decompensated Cirrhosis – This is a severe stage of liver cirrhosis where the liver can no longer perform its vital functions effectively. It often results from chronic liver damage due to conditions like hepatitis or long-term alcohol abuse. As the liver becomes increasingly scarred, symptoms such as jaundice, fluid accumulation in the abdomen (ascites), and confusion due to toxin buildup (hepatic encephalopathy) may occur. The disease progresses as liver function continues to decline, leading to complications like bleeding from enlarged veins in the esophagus or stomach. Patients may experience fatigue, weakness, and weight loss as the liver's ability to process nutrients and toxins diminishes. The progression of decompensated cirrhosis can vary, but it typically involves worsening liver function and increasing symptoms over time.