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

Официальное название

A Randomized Multicentre, Double-Blinded and Placebo-Controlled, Trial of Human Albumin in the Treatment of Decompensated Cirrhosis Guided by the MICROB-PREDICT Biomarker

Обзор

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.

Вмешательства

• Препарат 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)
• Препарат 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)

Первичные конечные точки

• Cumulative number of liver-related clinical outcomes [Срок оценки: 6 months]

Вторичные конечные точки (12)

• 6-months survival [Срок оценки: 6 months]
• The number of episodes of acute-on-chronic liver failures [Срок оценки: 6 months]
• Number of organ failures [Срок оценки: 6 months]
• Time-to-first liver-related clinical outcome [Срок оценки: 6 months]
• Change in SF-36 [Срок оценки: 6 months]
• Change in CLDQ [Срок оценки: 6 months]
• Change in EQ-5D-5L [Срок оценки: 6 months]
• Time to first hospital admission (in days) [Срок оценки: 180 days]
• Number of hospital admissions [Срок оценки: 180 days]
• Days spent on hospitalization (in days) [Срок оценки: 180 days]
• Number of intensive care unit admissions [Срок оценки: 180 days]
• Length of intensive care unit admissions (in days) [Срок оценки: 180 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Германия · 3 центра

• Charité - Universitätsmedizin Berlin — Berlin
• Universitätsklinikum Jena — Jena
• Universitätsklinikum Münster — Münster

Дания · 2 центра

• Herlev Hospital — Herlev
• Odense University Hospital — Odense

Нидерланды · 2 центра

• Academisch Ziekenhuis Leiden — Leiden
• Alrijne Ziekenhuis Leiden — Leiderdorp

Испания · 2 центра

• Hospital Clinic Barcelona — Barcelona
• Hospital Del Mar — Barcelona

Бельгия · 1 центр

• Katholieke Universiteit Leuven — Leuven

Венгрия · 1 центр

• Debreceni Egyetem — Debrecen

Великобритания · 1 центр

• King's College Hospital — London

Публикации

• 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 38355195

Идентификаторы

NCT: NCT05056220 · 2022-501006-34-01 · 825694

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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