Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites
NCT ID: NCT05056220
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
240 participants
INTERVENTIONAL
2024-02-26
2026-09-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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High expected effect: Human Albumin 20% + Standard Medical Treatment
Participants stratified to a high expected effect of human albumin and randomized to active treatment with 20% Human Albumin infusions.
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)
High expected effect: Saline (NaCl 0.9%) + Standard Medical Treatment
Participants stratified to a high expected effect of human albumin and randomized to placebo treatment with 0.9% NaCl (saline) infusions.
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)
Low expected effect: Human Albumin 20% + Standard Medical Treatment
Participants stratified to a low expected effect of human albumin and randomized to active treatment with 20% Human Albumin infusions.
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)
Low expected effect: Saline (NaCl 0.9%) + Standard Medical Treatment
Participants stratified to a low expected effect of human albumin and randomized to placebo treatment with 0.9% NaCl (saline) infusions.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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 cirrhosis who develop decompensation in the postoperative period following partial hepatectomy
* Refractory ascites as defined by the International Ascites Club
* Existing TIPS
* Portal vein thrombosis
* 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
18 Years
ALL
No
Sponsors
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EASL - CLIF Consortium
OTHER
Aleksander Krag
OTHER
Responsible Party
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Aleksander Krag
Professor
Principal Investigators
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Aleksander Krag, Professor
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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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
Barcelona, , Spain
King's College Hospital
London, , United Kingdom
Countries
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Central Contacts
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Jonel Trebicka, Professor
Role: CONTACT
Facility Contacts
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Wim Laleman
Role: primary
Mette Lehmann Andersen
Role: primary
Nikolaj Torp
Role: primary
Alexander Zipprich
Role: primary
Jonel Trebicka
Role: primary
Maria Papp
Role: primary
Minneke Coenraad
Role: primary
Sunje Abraham
Role: primary
Pere Ginés
Role: primary
Montserrat Garcia Retortillo
Role: primary
Debbie Shawcross
Role: primary
References
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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.
Other Identifiers
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825694
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2022-501006-34-01
Identifier Type: -
Identifier Source: org_study_id
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