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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05056220
Study type Interventional
Source Odense University Hospital
Contact Aleksander Krag, Professor
Phone +4566113333
Email albtrial@rsyd.dk
Status Recruiting
Phase Phase 3
Start date February 26, 2024
Completion date April 2025

See also
  Status Clinical Trial Phase
Recruiting NCT06121479 - Oral Branched-chain Amino Acid Supplementation for Decompensated Cirrhotic Patients Phase 3
Active, not recruiting NCT03451292 - Effects of Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites Phase 3