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.
Italy 
