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ALB-TRIAL: Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501006-34-01
Enrollment
210
Registered
2023-02-13
Start date
2023-03-29
Completion date
Unknown
Last updated
2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver cirrhosis

Brief summary

Cumulative number of liver-related clinical outcomes (variceal bleeding, ascites, spontaneous bacterial peritonitis, infection requiring hospitalization, acute kidney injury and overt hepatic encephalopathy) and TIPS (insertion or revision) with death and liver transplantation as counting and censoring events

Detailed description

6-months survival, The number of episodes of acute-on-chronic liver failures, Number of organ failures, Time-to-first liver-related clinical outcome, Patients’ quality of life, Time to first hospital admission (in days), Number of hospital admissions, Days spent on hospitalization (in days), Number of intensive care unit admissions, Length of intensive care unit admissions (in days), Number of large volume paracentesis, Analysis of the cost/effectiveness ratio, Health economic evaluation, Changes in serum albumin levels, Number of treatment-related adverse events, Number of treatment-related serious adverse events, Signatures associated with a poor prognosis as defined by the Microb-Predict biomarker, Incidence of refractory ascites, Incidence of variceal bleeding, Incidence of spontaneous bacterial peritonitis, Incidence of infection requiring hospitalization, Incidence of acute kidney injury >= 1B, Incidence of hepatorenal syndrome acute kidney injury, Incidence of overt hepatic encephalopathy, Incidence of liver transplantation, Incidence of TIPS insertion or revision

Interventions

Sponsors

Odense University Hospital, European Foundation For The Study Of Chronic Liver Failure
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Cumulative number of liver-related clinical outcomes (variceal bleeding, ascites, spontaneous bacterial peritonitis, infection requiring hospitalization, acute kidney injury and overt hepatic encephalopathy) and TIPS (insertion or revision) with death and liver transplantation as counting and censoring events

Secondary

MeasureTime frame
6-months survival, The number of episodes of acute-on-chronic liver failures, Number of organ failures, Time-to-first liver-related clinical outcome, Patients’ quality of life, Time to first hospital admission (in days), Number of hospital admissions, Days spent on hospitalization (in days), Number of intensive care unit admissions, Length of intensive care unit admissions (in days), Number of large volume paracentesis, Analysis of the cost/effectiveness ratio, Health economic evaluation, Changes in serum albumin levels, Number of treatment-related adverse events, Number of treatment-related serious adverse events, Signatures associated with a poor prognosis as defined by the Microb-Predict biomarker, Incidence of refractory ascites, Incidence of variceal bleeding, Incidence of spontaneous bacterial peritonitis, Incidence of infection requiring hospitalization, Incidence of acute kidney injury >= 1B, Incidence of hepatorenal syndrome acute kidney injury, Incidence of overt hepatic ence

Countries

Belgium, Denmark, Germany, Hungary, Netherlands, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 7, 2026