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Patients with liver cirrhosis and ascites experience frequent hospitalizations, a diminished quality of life, and high mortality rates. While human albumin has been used for decades to manage complications of cirrhosis, its effectiveness varies widely among patients, and long-term administration remains debated.
A more targeted approach is needed to optimize albumin therapy. Researchers in the MICROB-PREDICT Consortium have identified a panel of blood metabolites that could predict an individual patient’s response to human albumin treatment. The ALB-TRIAL aims to validate these biomarkers in a controlled clinical setting, . This approach is crucial as long-term human albumin administration is costly and resource-intensive for both patients and healthcare systems. By integrating predictive biomarkers into clinical decision-making, the ALB-TRIAL seeks to refine human albumin therapy within the standard-of-care, ensuring its use is both effective and sustainable for patients with cirrhosis and ascites.
The ALB-TRIAL is a double-blind, placebo-controlled, multicenter study conducted across hospitals in Belgium, Denmark, Germany, Hungary, Spain, the Netherlands, and the UK. The trial will enroll 240 patients with cirrhosis and ascites, who will first undergo an open-label human albumin challenge, where both clinical researchers and patients are aware of the treatment being given. Biomarker analysis, performed centrally at the University of Münster, Germany, will then classify them into two groups—high-expected or low-expected responders—before randomization into either human albumin treatment or placebo for six months.
The European Liver Patient Association (ELPA), a partner in the MICROB-PREDICT Consortium, played an active role in designing the trial, ensuring that patient perspectives were considered. ELPA’s input helped shape the study’s eligibility criteria and intervention burden, reinforcing the trial’s commitment to patient-centered research.
The primary outcome is the cumulative number of liver-related events, including complications, hospitalizations, liver transplants, and mortality. Secondary outcomes include time-to-event analysis, hospitalization rates, and cost-effectiveness assessments.
If successful, the the ALB-TRIAL will provide a robust, validated microbiome-based biomarker tool to guide personalized albumin therapy, reducing unnecessary treatments and optimizing patient care.
With patient recruitment now underway, researchers expect to gather data in the coming years. The trial’s results could pave the way for a paradigm shift in the treatment of cirrhosis and ascites, making long-term human albumin therapy as the standard of care for patients with decompensated cirrhosis in European countries.
Nikolaj Torp, predoctoral researcher at Odense University Hospital and first author of the protocol published in BMJ Open on 14 February 2024, says: “By having trial sites involved from across Europe, we are testing this intervention in various national healthcare system settings.”
“Given the validation of that our biomarker panel, we believe this will ensure a more swift adoption of long-term human albumin treatment for patients with complications of cirrhosis”, adds Aleksander Krag, Coordinator of the ALB-TRIAL and Director of the Odense Liver Research Centre at Odense University Hospital.
Other authors in the protocol are Mads Israelsen, Minneke Coenraad, Maria Papp, Debbie Shawcross, Marko Korenjak, Paolo Angeli, Wim Laleman, Adria Juanola, Pere Gines, Jonel Trebicka, MICROB-PREDICT Consortium.
Torp N, Israelsen M, Coenraad M, Papp M, Shawcross D, Korenjak M, Angeli P, Laleman W, Juanola A, Gines P, Trebicka J, Krag A; MICROB-PREDICT Consortium. Personalised human albumin in patients with cirrhosis and ascites: design and rationale for the ALB-TRIAL – A randomised clinical biomarker validation trial. BMJ Open 2024;14(2):e079309. DOI: 10.1136/bmjopen-2023-079309
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