Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-13 @ 3:31 PM
Study NCT ID:
NCT05056220
Status:
RECRUITING
Last Update Posted:
2025-08-05
First Post:
2021-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001201', 'term': 'Ascites'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000075462', 'term': 'Serum Albumin, Human'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D012709', 'term': 'Serum Albumin'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2021-09-20', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative number of liver-related clinical outcomes', 'timeFrame': '6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': '6-months survival', 'timeFrame': '6 months'}, {'measure': 'The number of episodes of acute-on-chronic liver failures', 'timeFrame': '6 months', 'description': 'Acute-on-chronic liver failure (ACLF) is defined according to the CLIF-C ACLF definition.'}, {'measure': 'Number of organ failures', 'timeFrame': '6 months', 'description': 'Where an organ failure is defined according to the CLIF-C ACLF definition.'}, {'measure': 'Time-to-first liver-related clinical outcome', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Change in SF-36', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Change in CLDQ', 'timeFrame': '6 months', 'description': '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).'}, {'measure': 'Change in EQ-5D-5L', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Time to first hospital admission (in days)', 'timeFrame': '180 days'}, {'measure': 'Number of hospital admissions', 'timeFrame': '180 days'}, {'measure': 'Days spent on hospitalization (in days)', 'timeFrame': '180 days'}, {'measure': 'Number of intensive care unit admissions', 'timeFrame': '180 days'}, {'measure': 'Length of intensive care unit admissions (in days)', 'timeFrame': '180 days'}, {'measure': 'Number of large volume paracentesis', 'timeFrame': '6 months'}, {'measure': 'Analysis of the cost/effectiveness ratio', 'timeFrame': '6 months', 'description': 'Analyzed by an incremental cost-effectiveness ratio (ICER) calculation'}, {'measure': 'Health economic evaluation', 'timeFrame': '6 months', 'description': 'Analyzed by the change in quality-adjusted life years (QALYs) relative to the ICER.'}, {'measure': 'Changes in serum albumin levels', 'timeFrame': '6 months', 'description': 'Measured from baseline and throughout the trial in grams per litre (g/L)'}, {'measure': 'Number of treatment-related adverse events', 'timeFrame': '6 months', 'description': 'Adverse events which are deemed related to the trial intervention'}, {'measure': 'Number of treatment-related serious adverse events', 'timeFrame': '6 months', 'description': 'Adverse events which are deemed related to the trial intervention'}, {'measure': 'Signatures associated with a poor prognosis as defined by the Microb-Predict biomarker', 'timeFrame': '6 months', 'description': 'Change in concentration of the panel of predictive circulating metabolites compared to metabolite levels in other body fluid compartments (blood, urin, stool and saliva)'}, {'measure': 'Incidence of refractory ascites', 'timeFrame': '6 months'}, {'measure': 'Incidence of variceal bleeding', 'timeFrame': '6 months'}, {'measure': 'Incidence of spontaneous bacterial peritonitis', 'timeFrame': '6 months'}, {'measure': 'Incidence of infection requiring hospitalization', 'timeFrame': '6 months'}, {'measure': 'Incidence of acute kidney injury >= 1B', 'timeFrame': '6 months', 'description': 'According to the Kidney Disease: Improving Global Outcomes (KDIGO) definition ranging from stage 1A to 3 where a higher stage is worse.'}, {'measure': 'Incidence of hepatorenal syndrome acute kidney injury', 'timeFrame': '6 months'}, {'measure': 'Incidence of overt hepatic encephalopathy', 'timeFrame': '6 months'}, {'measure': 'Incidence of liver transplantation', 'timeFrame': '6 months'}, {'measure': 'Incidence of TIPS insertion', 'timeFrame': '6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Decompensated Cirrhosis and Ascites']}, 'referencesModule': {'references': [{'pmid': '38355195', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* If the predictive biomarker panel can identify patients who are likely to benefit from regular human albumin infusions\n* If the predictive biomarker panel can lower the number-needed-to-treat of regular human albumin infusions in patients with liver cirrhosis and ascites\n\nThe 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.\n\nParticipants 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.\n\nResearchers will compare 20% human albumin infusions with regular 0.9% sodium chloride to identify the effects on the number of liver-related events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Decompensated liver cirrhosis defined as Child-Pugh score 7-12\n* Clinical and/or ultrasound evidenced ascites\n* Age ≥ 18 years\n* At least five days since resolution of a decompensation event or any condition requiring hospitalisation\n\nExclusion Criteria:\n\n* Patients with acute or subacute liver failure without underlying cirrhosis\n* Patients with cirrhosis who develop decompensation in the postoperative period following partial hepatectomy\n* Refractory ascites as defined by the International Ascites Club\n* Existing TIPS\n* Portal vein thrombosis\n* Severe alcoholic hepatitis (Glasgow Alcoholic Hepatitis Score \\> 11)\n* Hepatic encephalopathy grade III-IV\n* 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.)\n* Evidence of current malignancy except for non-melanocytic skin cancer and hepatocellular carcinoma within Barcelona Clinic Liver Cancer (BCLC)-0 or BCLC-A\n* 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)\n* HIV positive or other condition associated with and/or requiring immunosuppression\n* Previous liver or other transplantation\n* Pregnancy\n* Breastfeeding\n* 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\n* Physician's denial (investigator considers that the patient will not adhere to the study protocol scheduled, e.g. in case of heavy drinking)\n* Participation in another study within 3 months prior to screening"}, 'identificationModule': {'nctId': 'NCT05056220', 'briefTitle': 'Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'A Randomized Multicentre, Double-Blinded and Placebo-Controlled, Trial of Human Albumin in the Treatment of Decompensated Cirrhosis Guided by the MICROB-PREDICT Biomarker', 'orgStudyIdInfo': {'id': '2022-501006-34-01'}, 'secondaryIdInfos': [{'id': '825694', 'type': 'OTHER_GRANT', 'domain': 'HORIZON 2020'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High expected effect: Human Albumin 20% + Standard Medical Treatment', 'description': 'Participants stratified to a high expected effect of human albumin and randomized to active treatment with 20% Human Albumin infusions.', 'interventionNames': ['Drug: Human albumin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'High expected effect: Saline (NaCl 0.9%) + Standard Medical Treatment', 'description': 'Participants stratified to a high expected effect of human albumin and randomized to placebo treatment with 0.9% NaCl (saline) infusions.', 'interventionNames': ['Drug: sodium chloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low expected effect: Human Albumin 20% + Standard Medical Treatment', 'description': 'Participants stratified to a low expected effect of human albumin and randomized to active treatment with 20% Human Albumin infusions.', 'interventionNames': ['Drug: Human albumin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Low expected effect: Saline (NaCl 0.9%) + Standard Medical Treatment', 'description': 'Participants stratified to a low expected effect of human albumin and randomized to placebo treatment with 0.9% NaCl (saline) infusions.', 'interventionNames': ['Drug: sodium chloride']}], 'interventions': [{'name': 'Human albumin', 'type': 'DRUG', 'description': '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)', 'armGroupLabels': ['High expected effect: Human Albumin 20% + Standard Medical Treatment', 'Low expected effect: Human Albumin 20% + Standard Medical Treatment']}, {'name': 'sodium chloride', 'type': 'DRUG', 'description': '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)', 'armGroupLabels': ['High expected effect: Saline (NaCl 0.9%) + Standard Medical Treatment', 'Low expected effect: Saline (NaCl 0.9%) + Standard Medical Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Wim Laleman', 'role': 'CONTACT'}], 'facility': 'Katholieke Universiteit Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Herlev', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mette Lehmann Andersen', 'role': 'CONTACT'}], 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '5000', 'city': 'Odense', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Nikolaj Torp', 'role': 'CONTACT'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Berlin', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Jena', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Alexander Zipprich', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'Münster', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jonel Trebicka', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Debrecen', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Maria Papp', 'role': 'CONTACT'}], 'facility': 'Debreceni Egyetem', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'city': 'Leiden', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Minneke Coenraad', 'role': 'CONTACT'}], 'facility': 'Academisch Ziekenhuis Leiden', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Leiderdorp', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Sunje Abraham', 'role': 'CONTACT'}], 'facility': 'Alrijne Ziekenhuis Leiden', 'geoPoint': {'lat': 52.15833, 'lon': 4.52917}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pere Ginés', 'role': 'CONTACT'}], 'facility': 'Hospital Clinic Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Montserrat Garcia Retortillo', 'role': 'CONTACT'}], 'facility': 'Hospital Del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Debbie Shawcross', 'role': 'CONTACT'}], 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Aleksander Krag, Professor', 'role': 'CONTACT', 'email': 'albtrial@rsyd.dk', 'phone': '+4566113333'}, {'name': 'Jonel Trebicka, Professor', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Aleksander Krag, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aleksander Krag', 'class': 'OTHER'}, 'collaborators': [{'name': 'EASL - CLIF Consortium', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Aleksander Krag', 'investigatorAffiliation': 'Odense University Hospital'}}}}