Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites
Condition(s) studied
Investigational drug(s) / intervention(s)
Human albumin: 20% Human Albumin infusions (every 10th day +/- 4 days) with dosing according to the participants bodyweight (1.5 grams of albumin per kg bodyweight with a maximum of 100 grams)
sodium chloride: 0.9% NaCl infusions (every 10th day +/- 4 days) with dosing according to the corresponding volume used of 20% Human Albumin (1.5 grams of albumin per kg bodyweight with a maximum of 100 grams)
Study summary
The goal of this clinical biomarker validation trial is to test the effect of a predictive biomarker panel to human albumin infusions in patients with liver cirrhosis and ascites. The main questions it aims to answer are:
* If the predictive biomarker panel can identify patients who are likely to benefit from regular human albumin infusions
* If the predictive biomarker panel can lower the number-needed-to-treat of regular human albumin infusions in patients with liver cirrhosis and ascites
The predictive biomarker panel will stratify patients into either a high- or low-expected effect of human albumin infusions. Hereafter are participants randomized into treatment arms.
Participants in the active treatment arm will receive regular human albumin infusions during a course of 6 months. Infusions will occur every 10th day for the duration of the study.
Researchers will compare 20% human albumin infusions with regular 0.9% sodium chloride to identify the effects on the number of liver-related events.
Eligibility
Primary outcome measure(s)
- Cumulative number of liver-related clinical outcomes — 6 months
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
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| Katholieke Universiteit Leuven | Leuven | Belgium | Recruiting |
| Herlev Hospital | Herlev | Denmark | Recruiting |
| Odense University Hospital | Odense | Denmark | Recruiting |
| Charité - Universitätsmedizin Berlin | Berlin | Germany | Recruiting |
| Universitätsklinikum Jena | Jena | Germany | Recruiting |
| Universitätsklinikum Münster | Münster | Germany | Recruiting |
| Debreceni Egyetem | Debrecen | Hungary | Recruiting |
| Academisch Ziekenhuis Leiden | Leiden | Netherlands | Recruiting |
| Alrijne Ziekenhuis Leiden | Leiderdorp | Netherlands | Recruiting |
| Hospital Clinic Barcelona | Barcelona | Spain | Recruiting |
| Hospital Del Mar | Barcelona | Spain | Recruiting |
| King's College Hospital | London | United Kingdom | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05056220 on ClinicalTrials.gov ↗ ← All trials in Spain