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Glutathione (Reduced), Sodium Salt

This article discusses a clinical trial investigating the use of a restored human albumin solution (reHA) combined with glutathione in patients with decompensated cirrhosis. The study aims to evaluate the safety and effectiveness of this treatment compared to standard albumin solutions, focusing on improving albumin concentration and various clinical outcomes in patients requiring long-term albumin treatment.

Table of Contents

What is Glutathione?

Glutathione, specifically in its reduced form as a sodium salt, is the focus of this clinical trial. It’s a substance that’s being studied for its potential benefits in treating decompensated cirrhosis, a severe liver condition[1]. Glutathione is known by several names, including:

  • GLUTATHIONE (REDUCED), SODIUM SALT (scientific name)
  • RITION Glutatione (brand name)

In this study, glutathione is being used in combination with human albumin, a protein normally found in the blood, to potentially improve the treatment of patients with decompensated cirrhosis.

Medical Condition: Decompensated Cirrhosis

Decompensated cirrhosis is an advanced stage of liver disease where the liver can no longer function properly[1]. This condition can lead to various complications, including:

  • Accumulation of fluid in the abdomen (ascites)
  • Mental confusion (hepatic encephalopathy)
  • Kidney problems
  • Bleeding issues

These complications significantly impact a patient’s quality of life and require careful medical management.

Clinical Trial Overview

The clinical trial is designed to assess the safety and effectiveness of a special albumin solution containing glutathione for patients with decompensated cirrhosis[1]. The study aims to compare this new solution (called reHA) with standard albumin treatments currently used for these patients.

How Glutathione is Used in the Study

In this trial, glutathione is combined with human albumin to create a solution called reHA. This solution is administered to patients through intravenous (IV) infusion, which means it’s given directly into the bloodstream through a vein[1]. The dosage and frequency of administration include:

  • An initial dose of 0.5 grams per kilogram of body weight
  • Followed by 1 gram per kilogram of body weight (up to a maximum of 80 grams) a week later

The total treatment period lasts for 6 months, with regular check-ups at 1, 3, and 6 months after starting the treatment.

Eligibility Criteria

To participate in this study, patients must meet certain criteria[1]. Some key inclusion criteria are:

  • Diagnosed with liver cirrhosis
  • Have moderate to severe accumulation of fluid in the abdomen (ascites)
  • Be between 18 and 85 years old

Some reasons why a person might not be eligible include:

  • Recent albumin infusions (except for specific complications)
  • Active cancer (with some exceptions)
  • Severe kidney or heart problems
  • Pregnancy or breastfeeding

Potential Benefits

While the exact benefits are still being studied, researchers hope that this treatment might improve various aspects of liver function and overall health in patients with decompensated cirrhosis[1]. Some potential areas of improvement being monitored include:

  • Reduction in fluid accumulation in the abdomen
  • Improved mental function
  • Better kidney function
  • Overall improvement in liver function tests

Safety Considerations

As with any medical treatment, safety is a top priority in this study[1]. The researchers will be closely monitoring patients for any side effects or adverse reactions. Some safety measures include:

  • Regular check-ups and blood tests
  • Monitoring of vital signs
  • Recording any adverse events or reactions to the treatment

It’s important to note that patients with known allergies to albumin or glutathione preparations are not eligible for this study to avoid potential allergic reactions.

Aspect Details
Study Type Phase II clinical trial
Condition Decompensated cirrhosis
Intervention Restored human albumin (reHA) solution with glutathione
Comparison Standard commercial albumin solution
Primary Outcomes Effective albumin concentration, Safety assessment
Secondary Outcomes Organ function, Inflammation markers, Quality of life
Duration 6 months
Participant Age 18-85 years

FAQ

  • What is the main purpose of this clinical trial? The main purpose is to assess the impact on effective albumin concentration and the safety of administering a restored human albumin (reHA) solution compared to standard commercial albumin solutions in patients with decompensated cirrhosis who need long-term albumin treatment.
  • Who can participate in this clinical trial? Participants must be between 18 and 85 years old, diagnosed with liver cirrhosis, have grade 2 or 3 ascites (or grade 1 with diuretic treatment), and provide informed consent. However, there are several exclusion criteria, such as recent albumin infusion, ongoing acute complications, or certain other medical conditions.
  • What treatment will participants receive? Participants will be randomly assigned to receive either a 20% restored human albumin (reHA) solution mixed with pharmaceutical-grade glutathione or a standard 20% commercial albumin solution. The treatment will be administered over a 6-month period.
  • What are the primary outcomes being measured? The primary outcomes include the effective albumin concentration at 1, 3, and 6 months after starting treatment, and the safety of the reHA solution over the 6-month treatment period. Safety will be assessed by monitoring vital signs, lab parameters, and any adverse events.
  • How long does the clinical trial last? The main part of the trial lasts for 6 months, during which participants will receive treatment and be monitored for various outcomes. There is also an initial safety run-in phase conducted at the coordinating center before the main trial begins.

Ongoing Clinical Trials on Glutathione (Reduced), Sodium Salt

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

    Recruiting

    1 1 1
    Investigated drugs:
    Italy

Glossary

  • Decompensated cirrhosis: An advanced stage of liver disease where the liver can no longer function properly, leading to various complications such as fluid buildup in the abdomen (ascites), confusion (hepatic encephalopathy), and kidney problems.
  • Albumin: A protein made by the liver that helps maintain fluid balance in the body and carries various substances in the blood.
  • Ascites: Accumulation of fluid in the abdominal cavity, often seen in patients with advanced liver disease.
  • Glutathione: A naturally occurring antioxidant in the body that helps protect cells from damage and supports various bodily functions.
  • Hepatic encephalopathy (HE): A decline in brain function that occurs as a complication of liver disease, often causing confusion and other neurological symptoms.
  • Paracentesis: A procedure to remove excess fluid from the abdominal cavity, often performed in patients with ascites.
  • Spontaneous bacterial peritonitis (SBP): An infection of the fluid in the abdominal cavity, which can occur in patients with cirrhosis and ascites.
  • Acute kidney injury-hepatorenal syndrome (AKI-HRS): A severe complication of advanced liver disease where kidney function rapidly declines.
  • Trans jugular intrahepatic portosystemic shunt (TIPS): A medical procedure that creates a new route for blood to flow through the liver, used to treat complications of portal hypertension in cirrhosis.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-human-plasma-proteins-and-glutathione-for-patients-with-decompensated-cirrhosis/