Safety and efficacy of a human albumin solution with restored structural profile in patients with decompensated cirrhosis

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• • HA infusion in the prior 2 weeks except for paracentesis, spontaneous bacterial peritonitis (SBP) and acute kidney injury-hepatorenal syndrome (AKI-HRS); • Ongoing acute complications of cirrhosis; • Active malignancy except for hepatocellular carcinoma within Milan criteria; • Previous organ transplantation; • Trans jugular intrahepatic portosystemic shunt (TIPS) or Budd-Chiari syndrome; • Antiviral treatment for viral hepatitis started in the last 6 months; • Ongoing alcohol consumption with >21 alcohol U/week or an expected low adherence to protocol; • Chronic organic renal failure stage IV and V; • Chronic heart failure NYHA class III or IV; • Chronic obstructive pulmonary disease GOLD III or IV; • Life expectancy <6 months due to extrahepatic diseases; • Severe psychiatric disorders; • Known or suspected hypersensitivity to HA; • Pregnancy and breast-feeding; • Patients enrolled in other interventional clinical study for the treatment of complication of cirrhosis; • Use of experimental drugs for the last 2 months prior the inclusion in the present study • Hypersensitivity to albumin preparations or to any of the excipients; • Hypersensitivity to Glutathione or any component of the Glutathione solution; • Females of child-bearing potential are excluded unless they meet one of the following criteria: - Post-menopausal defined as no menses for 12 months without an alternative medical cause [89]. If post-menopausal for less than 12 months, a negative pregnancy test is required; - Surgical sterilization for more than one month duration and a negative pregnancy test (permanent sterilization methods include: hysterectomy, bilateral salpingectomy and bilateral oophorectomy) [89]; - Intrauterine device in combination with a secondary barrier (e.g. diaphragm, condom or spermicide) and a negative pregnancy test.