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

Aleksander Krag

Status and phase: Enrolling; Phase 3

Conditions: Decompensated Cirrhosis and Ascites

Treatments: Drug: sodium chloride; Drug: Human albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT05056220

2022-501006-34-01

825694 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 4 patient groups, including a placebo group

High expected effect: Human Albumin 20% + Standard Medical Treatment

Active Comparator group

Description:

Participants stratified to a high expected effect of human albumin and randomized to active treatment with 20% Human Albumin infusions.

Treatment:

Drug: Human albumin

High expected effect: Saline (NaCl 0.9%) + Standard Medical Treatment

Placebo Comparator group

Description:

Participants stratified to a high expected effect of human albumin and randomized to placebo treatment with 0.9% NaCl (saline) infusions.

Treatment:

Drug: sodium chloride

Low expected effect: Human Albumin 20% + Standard Medical Treatment

Active Comparator group

Description:

Participants stratified to a low expected effect of human albumin and randomized to active treatment with 20% Human Albumin infusions.

Treatment:

Drug: Human albumin

Low expected effect: Saline (NaCl 0.9%) + Standard Medical Treatment

Placebo Comparator group

Description:

Participants stratified to a low expected effect of human albumin and randomized to placebo treatment with 0.9% NaCl (saline) infusions.

Treatment:

Drug: sodium chloride