Personalized treatment with human albumin for patients with liver cirrhosis and fluid buildup

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of a predictive biomarker panel in identifying patients with decompensated cirrhosis and ascites who are likely to benefit from regular human albumin infusions. Participants will be stratified based on the biomarker panel into high- or low-expected effect groups and will receive either human albumin or sodium chloride infusions over a six-month period. The study seeks to determine if the biomarker can reduce the number of patients needed to treat to achieve beneficial outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Katholieke Universiteit Leuven
  Leuven, Belgium Recruiting
• Herlev Hospital
  Herlev, Denmark Recruiting
• Odense University Hospital
  Odense, Denmark Recruiting
• Charité - Universitätsmedizin Berlin
  Berlin, Germany Recruiting
• Universitätsklinikum Jena
  Jena, Germany Recruiting
• Universitätsklinikum Münster
  Münster, Germany Recruiting

Study contacts

• Principal investigator: Aleksander Krag, Professor — Odense University Hospital
• Study coordinator: Aleksander Krag, Professor
• Email: albtrial@rsyd.dk
• Phone: +4566113333

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.