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

ConditionDecompensated Cirrhosis and Ascites

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorAleksander Krag

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Human albumin
Drug
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
Drug
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)

Treatment groups

240 Participants

are divided into 4 treatment groups

Group A: High expected effect: Human Albumin 20% + Standard Medical TreatmentActive comparator 1 intervention

Group B: High expected effect: Saline (NaCl 0.9%) + Standard Medical TreatmentPlacebo comparator 1 intervention

Group C: Low expected effect: Human Albumin 20% + Standard Medical TreatmentActive comparator 1 intervention

Group D: Low expected effect: Saline (NaCl 0.9%) + Standard Medical TreatmentPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

6 months

Secondary outcomes

6-months survival

Time frame

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.

Time frame

6 months

Number of organ failures

Where an organ failure is defined according to the CLIF-C ACLF definition.

Time frame

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.

Time frame

6 months