Decompensated Cirrhosis and AscitesPhase 3NCT05056220
Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites
A Phase 3 study testing Human albumin and sodium chloride in people with Decompensated Cirrhosis and Ascites, run by Aleksander Krag at 12 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompensated Cirrhosis and Ascites
- What is being tested?
- Human albumin and sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 12 sitesin 7 countries
- Study dates
- 26 Feb 2024to Sep 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
12 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
Jonel Trebicka, Professor contact
12 sites in 7 countries
Germany3 sites, 3 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin
Cornelius Engelmann
- Recruiting
Universitätsklinikum Jena
Jena
Alexander Zipprich
- Recruiting
Universitätsklinikum Münster
Münster
Jonel Trebicka
Denmark2 sites, 2 recruiting
- Recruiting
Herlev Hospital
Herlev
Mette Lehmann Andersen
- Recruiting
Odense University Hospital
Odense, 5000
Nikolaj Torp
Netherlands2 sites, 2 recruiting
- Recruiting
Academisch Ziekenhuis Leiden
Leiden
Minneke Coenraad
- Recruiting
Alrijne Ziekenhuis Leiden
Leiderdorp
Sunje Abraham
Spain2 sites, 2 recruiting
- Recruiting
Hospital Clinic Barcelona
Barcelona
Pere Ginés
- Recruiting
Hospital Del Mar
Barcelona
Montserrat Garcia Retortillo
Belgium1 site, 1 recruiting
- Recruiting
Katholieke Universiteit Leuven
Leuven
Wim Laleman
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital
London
Debbie Shawcross
About this study
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
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
Read more
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.
- Conditions
- Decompensated Cirrhosis and Ascites
- Being tested
- Human albumin, sodium chloride
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (28)
6-months survival
Measured: 6 months
The number of episodes of acute-on-chronic liver failures
Acute-on-chronic liver failure (ACLF) is defined according to the CLIF-C ACLF definition.
Measured: 6 months
Number of organ failures
Where an organ failure is defined according to the CLIF-C ACLF definition.
Measured: 6 months
Time-to-first liver-related clinical outcome
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.
Measured: 6 months
Change in SF-36
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.
Measured: 6 months
Change in CLDQ
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).
Measured: 6 months
Change in EQ-5D-5L
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.
Measured: 6 months
Time to first hospital admission (in days)
Measured: 180 days
Number of hospital admissions
Measured: 180 days
Days spent on hospitalization (in days)
Measured: 180 days
Number of intensive care unit admissions
Measured: 180 days
Length of intensive care unit admissions (in days)
Measured: 180 days
Number of large volume paracentesis
Measured: 6 months
Analysis of the cost/effectiveness ratio
Analyzed by an incremental cost-effectiveness ratio (ICER) calculation
Measured: 6 months
Health economic evaluation
Analyzed by the change in quality-adjusted life years (QALYs) relative to the ICER.
Measured: 6 months
Changes in serum albumin levels
Measured from baseline and throughout the trial in grams per litre (g/L)
Measured: 6 months
Number of treatment-related adverse events
Adverse events which are deemed related to the trial intervention
Measured: 6 months
Number of treatment-related serious adverse events
Adverse events which are deemed related to the trial intervention
Measured: 6 months
Signatures associated with a poor prognosis as defined by the Microb-Predict biomarker
Change in concentration of the panel of predictive circulating metabolites compared to metabolite levels in other body fluid compartments (blood, urin, stool and saliva)
Measured: 6 months
Incidence of refractory ascites
Measured: 6 months
Incidence of variceal bleeding
Measured: 6 months
Incidence of spontaneous bacterial peritonitis
Measured: 6 months
Incidence of infection requiring hospitalization
Measured: 6 months
Incidence of acute kidney injury >= 1B
According to the Kidney Disease: Improving Global Outcomes (KDIGO) definition ranging from stage 1A to 3 where a higher stage is worse.
Measured: 6 months
Incidence of hepatorenal syndrome acute kidney injury
Measured: 6 months
Incidence of overt hepatic encephalopathy
Measured: 6 months
Incidence of liver transplantation
Measured: 6 months
Incidence of TIPS insertion or revision
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start26 Feb 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Decompensated Cirrhosis and AscitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aleksander Krag
- Sponsor type
- University, hospital or other
- Collaborators
- EASL - CLIF Consortium
- Responsible party
- Sponsor-investigator, Aleksander Krag, Odense University Hospital
- Investigators
- Aleksander Krag, Professor, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056220
- Sponsor's protocol ID
- 2022-501006-34-01
- Other IDs
- 825694
- Status last verified
- Jan 2026
- First submitted
- 20 Sep 2021
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38355195