In short
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.
At a glance
- 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
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. 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. 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. 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. 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. 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. 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. 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.