Actively Recruiting
Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites
Led by Aleksander Krag · Updated on 2026-02-03
240
Participants Needed
12
Research Sites
131 weeks
Total Duration
On this page
Sponsors
A
Aleksander Krag
Lead Sponsor
E
EASL - CLIF Consortium
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Decompensated liver cirrhosis defined as Child-Pugh score 7-12
- Clinical and/or ultrasound evidenced ascites
- Age 21 18 years
- At least five days since resolution of a decompensation event or any condition requiring hospitalisation
You will not qualify if you...
- Acute or subacute liver failure without underlying cirrhosis
- Decompensation after partial hepatectomy in cirrhosis patients
- Refractory ascites as defined by the International Ascites Club
- Existing TIPS inserted less than 6 months ago
- Portal vein thrombosis without cavernous transformation or recanalization
- Severe alcoholic hepatitis with Glasgow Alcoholic Hepatitis Score over 11
- Hepatic encephalopathy grade III-IV
- Current, planned, or recent (last 6 months) treatment with direct antiviral agents for hepatitis C
- Contraindications for human albumin infusion such as pulmonary edema or hypersensitivity
- Current malignancy except non-melanocytic skin cancer and early-stage hepatocellular carcinoma
- Severe extra-hepatic diseases including chronic renal failure requiring hemodialysis, severe heart disease (NYHA > II), severe chronic pulmonary disease (GOLD 21 C), severe neurological or psychiatric disorders, pulmonary arterial hypertension
- HIV positive or requiring immunosuppression
- Previous liver or other transplantation
- Pregnancy
- Breastfeeding
- Unable or unwilling to provide informed consent
- Physician's denial based on expected non-adherence (e.g., heavy drinking)
- Participation in another study within 3 months prior to screening
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Katholieke Universiteit Leuven
Leuven, Belgium
Actively Recruiting
2
Herlev Hospital
Herlev, Denmark
Actively Recruiting
3
Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
4
Charité - Universitätsmedizin Berlin
Berlin, Germany
Actively Recruiting
5
Universitätsklinikum Jena
Jena, Germany
Actively Recruiting
6
Universitätsklinikum Münster
Münster, Germany
Actively Recruiting
7
Debreceni Egyetem
Debrecen, Hungary
Actively Recruiting
8
Academisch Ziekenhuis Leiden
Leiden, Netherlands
Actively Recruiting
9
Alrijne Ziekenhuis Leiden
Leiderdorp, Netherlands
Actively Recruiting
10
Hospital Clinic Barcelona
Barcelona, Spain
Actively Recruiting
11
Hospital Del Mar
Barcelona, Spain
Actively Recruiting
12
King's College Hospital
London, United Kingdom
Actively Recruiting
Research Team
A
Aleksander Krag, Professor
CONTACT
J
Jonel Trebicka, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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