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Recruiting Phase 3

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

NCT05056220 · tracked via the Priya Life Science Germany tracker
Sponsor
Aleksander Krag
Phase
Phase 3
Started
2024-02-26
Last updated
2026-02-03

Condition(s) studied

Decompensated Cirrhosis and Ascites

Investigational drug(s) / intervention(s)

Human albumin →sodium chloride

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)

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)

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Cumulative number of liver-related clinical outcomes — 6 months
    Cumulative number of liver-related clinical outcomes (variceal bleeding, ascites, spontaneous bacterial peritonitis, infection requiring hospitalization, acute kidney injury and overt hepatic encephalopathy) and TIPS (insertion or revision) with death and liver transplantation as counting and censoring events

Trial sites (12)

FacilityCityRegionStatus
Katholieke Universiteit Leuven Leuven Belgium Recruiting
Herlev Hospital Herlev Denmark Recruiting
Odense University Hospital Odense Denmark Recruiting
Charité - Universitätsmedizin Berlin Berlin Germany Recruiting
Universitätsklinikum Jena Jena Germany Recruiting
Universitätsklinikum Münster Münster Germany Recruiting
Debreceni Egyetem Debrecen Hungary Recruiting
Academisch Ziekenhuis Leiden Leiden Netherlands Recruiting
Alrijne Ziekenhuis Leiden Leiderdorp Netherlands Recruiting
Hospital Clinic Barcelona Barcelona Spain Recruiting
Hospital Del Mar Barcelona Spain Recruiting
King's College Hospital London United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05056220 on ClinicalTrials.gov ↗ ← All trials in Germany