RecruitingPhase 3NCT05056220

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


Sponsor

Aleksander Krag

Enrollment

240 participants

Start Date

Feb 26, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Human albumin and a drug called sodium chloride for people with decompensated cirrhosis and ascites. The study is currently recruiting participants at 12 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHuman 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)

DRUGsodium 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)


Locations(12)

Katholieke Universiteit Leuven

Leuven, Belgium

Herlev Hospital

Herlev, Denmark

Odense University Hospital

Odense, Denmark

Charité - Universitätsmedizin Berlin

Berlin, Germany

Universitätsklinikum Jena

Jena, Germany

Universitätsklinikum Münster

Münster, Germany

Debreceni Egyetem

Debrecen, Hungary

Academisch Ziekenhuis Leiden

Leiden, Netherlands

Alrijne Ziekenhuis Leiden

Leiderdorp, Netherlands

Hospital Clinic Barcelona

Barcelona, Spain

Hospital Del Mar

Barcelona, Spain

King's College Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05056220


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