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RECRUITING

NCT05056220

PHASE3

Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites

Sponsor: Aleksander Krag

View on ClinicalTrials.gov

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.

Official title: A Randomized Multicentre, Double-Blinded and Placebo-Controlled, Trial of Human Albumin in the Treatment of Decompensated Cirrhosis Guided by the MICROB-PREDICT Biomarker

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2024-02-26

Completion Date

2026-09

Last Updated

2026-02-03

Healthy Volunteers

Conditions

Decompensated Cirrhosis and Ascites

Interventions

DRUG

Human 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)

DRUG

sodium 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)

Inclusion Criteria: * 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 Exclusion Criteria: * Patients with acute or subacute liver failure without underlying cirrhosis * Patients with cirrhosis who develop decompensation in the postoperative period following partial hepatectomy * Refractory ascites as defined by the International Ascites Club * Existing TIPS inserted \<6 months ago * Portal vein thrombosis without signs of cavernous transformation or recanalization * Severe alcoholic hepatitis (Glasgow Alcoholic Hepatitis Score \> 11) * Hepatic encephalopathy grade III-IV * Current, planned or previous treatment with direct antiviral agents for hepatitis C virus (HCV) in the last six months Contraindications for human albumin infusion (pulmonary oedema, hypersensitivity etc.) * Evidence of current malignancy except for non-melanocytic skin cancer and hepatocellular carcinoma within Barcelona Clinic Liver Cancer (BCLC)-0 or BCLC-A * Presence or history of severe extra-hepatic diseases (e.g.,chronic renal failure requiring hemodialysis, severe heart disease (NYHA \> II); severe chronic pulmonary disease (GOLD Score ≥ C), severe neurological and psychiatric disorders, pulmonary arterial hypertension) * HIV positive or other condition associated with and/or requiring immunosuppression * Previous liver or other transplantation * Pregnancy * Breastfeeding * Patients who decline to participate, patients who cannot provide prior written informed consent due to other causes than hepatic encephalopathy or patients with hepatic encephalopathy who cannot provide prior written informed consent and when there is documented evidence that the patient has no legal surrogate decision maker or sufficient ability to provide delayed informed consent * Physician's denial (investigator considers that the patient will not adhere to the study protocol scheduled, e.g. in case of heavy drinking) * Participation in another study within 3 months prior to screening

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