A Randomized Multicentre, Double-Blinded and Placebo-Controlled, Trial of Human Albumin in the Treatment of Decompensated Cirrhosis Guided by the MICROB-PREDICT Biomarker
Who is this study for? Patients with Decompensated Cirrhosis and Ascites
What treatments are being studied? Human Albumin
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Decompensated liver cirrhosis defined as Child-Pugh score 7-12
• Clinical and/or ultrasound evidenced ascites
• Age ≥ 18 years
• At least five days since resolution of a decompensation event or any condition requiring hospitalisation
Locations
Other Locations
Belgium
Katholieke Universiteit Leuven
RECRUITING
Leuven
Denmark
Herlev Hospital
RECRUITING
Herlev
Odense University Hospital
RECRUITING
Odense
Germany
Charité - Universitätsmedizin Berlin
ACTIVE_NOT_RECRUITING
Berlin
Universitätsklinikum Jena
NOT_YET_RECRUITING
Jena
Universitätsklinikum Münster
RECRUITING
Münster
Hungary
Debreceni Egyetem
RECRUITING
Debrecen
Netherlands
Academisch Ziekenhuis Leiden
RECRUITING
Leiden
Alrijne Ziekenhuis Leiden
RECRUITING
Leiderdorp
Spain
Hospital Clinic Barcelona
RECRUITING
Barcelona
Hospital Del Mar
RECRUITING
Barcelona
United Kingdom
King's College Hospital
NOT_YET_RECRUITING
London
Contact Information
Primary
Aleksander Krag, Professor
albtrial@rsyd.dk
+4566113333
Backup
Jonel Trebicka, Professor
Time Frame
Start Date:2024-02-26
Estimated Completion Date:2026-09
Participants
Target number of participants:240
Treatments
Active_comparator: High expected effect: Human Albumin 20% + Standard Medical Treatment
Participants stratified to a high expected effect of human albumin and randomized to active treatment with 20% Human Albumin infusions.
Placebo_comparator: High expected effect: Saline (NaCl 0.9%) + Standard Medical Treatment
Participants stratified to a high expected effect of human albumin and randomized to placebo treatment with 0.9% NaCl (saline) infusions.
Active_comparator: Low expected effect: Human Albumin 20% + Standard Medical Treatment
Participants stratified to a low expected effect of human albumin and randomized to active treatment with 20% Human Albumin infusions.
Placebo_comparator: Low expected effect: Saline (NaCl 0.9%) + Standard Medical Treatment
Participants stratified to a low expected effect of human albumin and randomized to placebo treatment with 0.9% NaCl (saline) infusions.