NCT05056220

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

A Randomized Multicentre, Double-Blinded and Placebo-Controlled, Trial of Human Albumin in the Treatment of Decompensated Cirrhosis Guided by the MICROB-PREDICT Biomarker

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Aleksander Krag · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Decompensated Cirrhosis and Ascites

Interventions

Type	Name	Description
DRUG	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)
DRUG	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)

Timeline

• Start date: 2024-02-26
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2021-09-24
• Last updated: 2026-02-03

Locations

12 sites across 7 countries: Belgium, Denmark, Germany, Hungary, Netherlands, Spain, United Kingdom