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

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 conditionrequiring hospitalisation

Exclusion Criteria:

• Patients with acute or subacute liver failure without underlying cirrhosis

• Patients with cirrhosis who develop decompensation in the postoperative periodfollowing partial hepatectomy

• Refractory ascites as defined by the International Ascites Club

• Existing TIPS

• Portal vein thrombosis

• Severe alcoholic hepatitis (Glasgow Alcoholic Hepatitis Score > 11)

• Hepatic encephalopathy grade III-IV

• Current, planned or previous treatment with direct antiviral agents for hepatitis Cvirus (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 andhepatocellular carcinoma within Barcelona Clinic Liver Cancer (BCLC)-0 or BCLC-A

• Presence or history of severe extra-hepatic diseases (e.g.,chronic renal failurerequiring hemodialysis, severe heart disease (NYHA > II); severe chronic pulmonarydisease (GOLD Score ≥ C), severe neurological and psychiatric disorders, pulmonaryarterial 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 writteninformed consent due to other causes than hepatic encephalopathy or patients withhepatic encephalopathy who cannot provide prior written informed consent and whenthere is documented evidence that the patient has no legal surrogate decision makeror sufficient ability to provide delayed informed consent

• Physician's denial (investigator considers that the patient will not adhere to thestudy protocol scheduled, e.g. in case of heavy drinking)

• Participation in another study within 3 months prior to screening