NCT05056220

Brief 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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
4mo left

Started Feb 2024

Typical duration for phase_3

Geographic Reach
7 countries

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Feb 2024Sep 2026

First Submitted

Initial submission to the registry

September 20, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
2.4 years until next milestone

Study Start

First participant enrolled

February 26, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

September 20, 2021

Last Update Submit

January 30, 2026

Conditions

Decompensated Cirrhosis and Ascites

Outcome Measures

Primary Outcomes (1)

  • Cumulative number of liver-related clinical outcomes

    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

    6 months

Secondary Outcomes (28)

  • 6-months survival

    6 months

  • The number of episodes of acute-on-chronic liver failures

    6 months

  • Number of organ failures

    6 months

  • Time-to-first liver-related clinical outcome

    6 months

  • Change in SF-36

    6 months

  • +23 more secondary outcomes

Study Arms (4)

High expected effect: Human Albumin 20% + Standard Medical Treatment

ACTIVE COMPARATOR

Participants stratified to a high expected effect of human albumin and randomized to active treatment with 20% Human Albumin infusions.

Drug: Human albumin

High expected effect: Saline (NaCl 0.9%) + Standard Medical Treatment

PLACEBO COMPARATOR

Participants stratified to a high expected effect of human albumin and randomized to placebo treatment with 0.9% NaCl (saline) infusions.

Drug: sodium chloride

Low expected effect: Human Albumin 20% + Standard Medical Treatment

ACTIVE COMPARATOR

Participants stratified to a low expected effect of human albumin and randomized to active treatment with 20% Human Albumin infusions.

Drug: Human albumin

Low expected effect: Saline (NaCl 0.9%) + Standard Medical Treatment

PLACEBO COMPARATOR

Participants stratified to a low expected effect of human albumin and randomized to placebo treatment with 0.9% NaCl (saline) infusions.

Drug: sodium chloride

Interventions

sodium chlorideDRUG

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)

High expected effect: Saline (NaCl 0.9%) + Standard Medical TreatmentLow expected effect: Saline (NaCl 0.9%) + Standard Medical Treatment
Human albuminDRUG

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)

High expected effect: Human Albumin 20% + Standard Medical TreatmentLow expected effect: Human Albumin 20% + Standard Medical Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Katholieke Universiteit Leuven

Leuven, Belgium

RECRUITING

Herlev Hospital

Herlev, Denmark

RECRUITING

Odense University Hospital

Odense, 5000, 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

Related Publications (1)

  • 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 Feb 14;14(2):e079309. doi: 10.1136/bmjopen-2023-079309.

    PMID: 38355195DERIVED

MeSH Terms

Conditions

Ascites

Interventions

Serum Albumin, HumanSodium Chloride

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serum AlbuminAlbuminsProteinsAmino Acids, Peptides, and ProteinsBlood ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Aleksander Krag, Professor

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksander Krag, Professor

CONTACT

+4566113333albtrial@rsyd.dk

Jonel Trebicka, Professor

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
There will exist two levels of masking in the current trial. Masking of biostratification outcome (high expected effect of human albumin or low expected effect of human albumin): Participant, Investigator and Outcome Assessor Masking of treatment assignment (human albumin 20% or saline 0.9%): Participant and Outcome Assessor
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 20, 2021

First Posted

September 24, 2021

Study Start

February 26, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations

ES(2)DE(3)HU(1)GB(1)NL(2)DK(2)BE(1)