GLUTATHIONE (REDUCED), SODIUM SALT for Decompensated cirrhosis

Inclusion criteria

• {"criterion_text":"- •\tDiagnosis of liver cirrhosis of any etiology (based on clinical, laboratory, endoscopic and ultrasonographic features);\n- •\tPatients with grade 2 and 3 ascites according to the criteria of the International Club of Ascites [88] and patients with grade 1 receiving diuretic treatment (at least 200 mg/die of an antialdosteronic drug ± furosemide 25 mg/die);\n- •\tPatients of both sexes aged between 18 and 85 years;\n- •\tWritten and autonomous informed consent."}

Exclusion criteria

• {"criterion_text":"- •\tHA infusion in the prior 2 weeks except for paracentesis, spontaneous bacterial peritonitis (SBP) and acute kidney injury-hepatorenal syndrome (AKI-HRS);\n- •\tOngoing acute complications of cirrhosis;\n- •\tActive malignancy except for hepatocellular carcinoma within Milan criteria;\n- •\tPrevious organ transplantation;\n- •\tTrans jugular intrahepatic portosystemic shunt (TIPS) or Budd-Chiari syndrome;\n- •\tAntiviral treatment for viral hepatitis started in the last 6 months;\n- •\tOngoing alcohol consumption with >21 alcohol U/week or an expected low adherence to protocol;\n- •\tChronic organic renal failure stage IV and V;\n- •\tChronic heart failure NYHA class III or IV;\n- •\tChronic obstructive pulmonary disease GOLD III or IV;\n- •\tLife expectancy <6 months due to extrahepatic diseases;\n- •\tSevere psychiatric disorders;\n- •\tKnown or suspected hypersensitivity to HA;\n- •\tPregnancy and breast-feeding;\n- •\tPatients enrolled in other interventional clinical study for the treatment of complication of cirrhosis;\n- •\tUse of experimental drugs for the last 2 months prior the inclusion in the present study \n- •\tHypersensitivity to albumin preparations or to any of the excipients;\n- •\tHypersensitivity to Glutathione or any component of the Glutathione solution;\n- •\tFemales of child-bearing potential are excluded unless they meet one of the following criteria: -\tPost-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; -\tSurgical sterilization for more than one month duration and a negative pregnancy test (permanent sterilization methods include: hysterectomy, bilateral salpingectomy and bilateral oophorectomy) [89]; -\tIntrauterine device in combination with a secondary barrier (e.g. diaphragm, condom or spermicide) and a negative pregnancy test."}

Primary endpoints

• {"endpoint_text":"- Primary endpoints of the study will be: -\tEffective albumin concentration at 1, 3 and 6 months from randomization\n- \tSafety of the reHA solution during the 6-month treatment assessed by collecting vital signs, lab parameters and any adverse event, namely: •\tPercentage of subjects with at least 1 adverse event (AE) or serious adverse event (SAE); •\tPercentage of subjects with at least 1 Adverse Drug Reaction (ADR); •Total number of AE, SAE and ADR; [truncated text, see protocol for details]","definition_or_measurement_approach":"Effective albumin concentration measured at 1, 3 and 6 months from randomization. Safety assessed during the 6-month treatment by collecting vital signs, laboratory parameters and adverse event reporting, including percentage of subjects with ≥1 AE/SAE, percentage with ≥1 ADR and total number of AE/SAE/ADR (detailed procedures referenced in protocol)."}

Secondary endpoints

• {"endpoint_text":"- Signals of efficacy will be searched by comparing the following parameters at 1, 3 and 6 months from randomization: Organ function: Liver function: grade of ascites (International Club of Ascites criteria), grade of HE (West Haven classification and Animal Naming Test), bilirubin and albumin serum levels; Renal function: BUN, serum creatinine, electrolytes, eGFR estimated by the CKD-EPI equation;[truncated text, see protocol for details]","definition_or_measurement_approach":"Comparison of listed organ function and surrogate markers at 1, 3 and 6 months from randomization, including clinical grading scales (ascites grade, West Haven for HE), Animal Naming Test, and laboratory measures (bilirubin, albumin, BUN, creatinine, electrolytes, eGFR by CKD-EPI)."}

Italy

Earliest CTIS Part Ii Submission Date

30-09-2024

Latest Decision Or Authorization Date

06-05-2026

Processing Time Days

583

Number Of Sites

4

Number Of Participants

88

Primary sponsor

Full Name

Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Yghea Ecol Studio S.p.A.","duties_or_roles":"Codes: 1,5,8 (as provided in sponsorDuties)","organisation_type":"Health care"}