decompensated cirrhosis
Conditions
Brief summary
Primary endpoints of the study will be: - Effective albumin concentration at 1, 3 and 6 months from randomization - Safety of the reHA solution during the 6-month treatment assessed by collecting vital signs, lab parameters and any adverse event, namely: • Percentage of subjects with at least 1 adverse event (AE) or serious adverse event (SAE); • Percentage of subjects with at least 1 Adverse Drug Reaction (ADR); •Total number of AE, SAE and ADR; [truncated text, see protocol for details]
Detailed description
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]
Interventions
DRUGRITION Glutatione
DRUGAlbunorm 20% "200 g/l
DRUGsoluzione per infusione"
Sponsors
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints of the study will be: - Effective albumin concentration at 1, 3 and 6 months from randomization - Safety of the reHA solution during the 6-month treatment assessed by collecting vital signs, lab parameters and any adverse event, namely: • Percentage of subjects with at least 1 adverse event (AE) or serious adverse event (SAE); • Percentage of subjects with at least 1 Adverse Drug Reaction (ADR); •Total number of AE, SAE and ADR; [truncated text, see protocol for details] | — |
Secondary
| Measure | Time frame |
|---|---|
| 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] | — |
Countries
Italy
Outcome results
None listed