An European multinational study of a personalized approach of human albumin administration in patients with cirrhosis of the liver and complications

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

Decompensated liver cirrhosis defined as Child-Pugh score 7-12, Clinical and/or ultrasound evidenced ascites, Age above or equal to 18 years, At least five days since resolution of a decompensation event or any condition requiring hospitalization

Exclusion Criteria

Patients with acute or subacute liver failure without underlying cirrhosis, Refractory ascites as defined by the International Ascites Club, Existing TIPS, Portal vein thrombosis, Severe alcoholic hepatitis (Glasgow Alcoholic Hepatitis Score > 11), Current, planned or previous treatment with direct antiviral agents for 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 BCLC-0 or BCLC-A, Hepatic encephalopathy grade III-IV, Participation in another study within 3 months prior to screening, Presence or history of severe extra-hepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe heart disease (NYHA above grade II), severe chronic pulmonary disease (GOLD Score above or equal to grade 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 or who cannot provide prior written informed consent and when there is documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness 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), Patients with cirrhosis who develop decompensation in the postoperative period following partial hepatectomy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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