Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05056220

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Decompensated Cirrhosis and Ascites Ascites Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Katholieke Universiteit Leuven, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human albumin

Drug

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

Drug

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)

Primary outcomes

  1. Cumulative number of liver-related clinical outcomes

    Time frame: 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

Secondary outcomes

  1. 6-months survival

    Time frame: 6 months

  2. The number of episodes of acute-on-chronic liver failures

    Time frame: 6 months

    Acute-on-chronic liver failure (ACLF) is defined according to the CLIF-C ACLF definition.

  3. Number of organ failures

    Time frame: 6 months

    Where an organ failure is defined according to the CLIF-C ACLF definition.

  4. Time-to-first liver-related clinical outcome

    Time frame: 6 months

    A liver-related clinical outcome is defined as variceal bleeding, ascites, spontaneous bacterial peritonitis, infection requiring hospitalization, acute kidney injury (>=1B), overt hepatic encephalopathy, TIPS insertion, liver transplantation or death. Time to any of these outcomes are defined as the time from trial inclusion until 1) the date of diagnosis of any of the complications, 2) the date of the procedure (TIPS or liver transplantation) or date of death.

  5. Change in SF-36

    Time frame: 6 months

    Quality of life for participants, as measured by Short Form 36 (SF-36), ranging from 0 to 100 with a score of 0 equal to maximum disability and score of 100 no disability.

  6. Change in CLDQ

    Time frame: 6 months

    Quality of life for participants, as measured by the Chronic Liver Disease Questionnaire (CLDQ), consisting of 29 items within 7 domains. Response on a Likert scale ranging from 1 (most impairment) to 7 (least impairment). Total score by adding score for each item and divide by number of items (29).

  7. Change in EQ-5D-5L

    Time frame: 6 months

    Quality of life for participants, as measured by the EuroQoL-5 Domain, 5 levels (EQ-5D-5L). Consist of 5 domains with 5 levels where the lowest level (1) is the worst imaginable health and highest level (5) is the best imaginable health.

  8. Time to first hospital admission (in days)

    Time frame: 180 days

  9. Number of hospital admissions

    Time frame: 180 days

  10. Days spent on hospitalization (in days)

    Time frame: 180 days

  11. Number of intensive care unit admissions

    Time frame: 180 days

  12. Length of intensive care unit admissions (in days)

    Time frame: 180 days

  13. Number of large volume paracentesis

    Time frame: 6 months

  14. Analysis of the cost/effectiveness ratio

    Time frame: 6 months

    Analyzed by an incremental cost-effectiveness ratio (ICER) calculation

  15. Health economic evaluation

    Time frame: 6 months

    Analyzed by the change in quality-adjusted life years (QALYs) relative to the ICER.

  16. Changes in serum albumin levels

    Time frame: 6 months

    Measured from baseline and throughout the trial in grams per litre (g/L)

  17. Number of treatment-related adverse events

    Time frame: 6 months

    Adverse events which are deemed related to the trial intervention

  18. Number of treatment-related serious adverse events

    Time frame: 6 months

    Adverse events which are deemed related to the trial intervention

  19. Signatures associated with a poor prognosis as defined by the Microb-Predict biomarker

    Time frame: 6 months

    Change in concentration of the panel of predictive circulating metabolites compared to metabolite levels in other body fluid compartments (blood, urin, stool and saliva)

  20. Incidence of refractory ascites

    Time frame: 6 months

  21. Incidence of variceal bleeding

    Time frame: 6 months

  22. Incidence of spontaneous bacterial peritonitis

    Time frame: 6 months

  23. Incidence of infection requiring hospitalization

    Time frame: 6 months

  24. Incidence of acute kidney injury >= 1B

    Time frame: 6 months

    According to the Kidney Disease: Improving Global Outcomes (KDIGO) definition ranging from stage 1A to 3 where a higher stage is worse.

  25. Incidence of hepatorenal syndrome acute kidney injury

    Time frame: 6 months

  26. Incidence of overt hepatic encephalopathy

    Time frame: 6 months

  27. Incidence of liver transplantation

    Time frame: 6 months

  28. Incidence of TIPS insertion or revision

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksander Krag, Professor

CONTACT

[email protected]

+4566113333

Jonel Trebicka, Professor

CONTACT

Sponsors and collaborators

Lead sponsor

Aleksander Krag

Other

Collaborators

  • EASL - CLIF Consortium

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 24, 2021
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.