Ensayos clínicos

Inclusion Criteria:

• Male or female subject ≥ 18 years of age.
• Subjects with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology) and uncomplicated ascites according to the ICA criteria.
• Subjects who have been discharged after hospitalization within the last 28 days for acute decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy) with or without ACLF at admission or during hospitalization but without ACLF at Screening.
• Subjects with ongoing diuretic treatment with an anti-mineralocorticoid drug at a dose of ≥100 mg/day and/or furosemide ≥40 mg/day or equivalent doses, independent of response to treatment.
• In subjects with cirrhosis due to hepatitis B virus, decompensation must occur in the setting of continuous (no less than 3 months) appropriate antiviral therapy.
• In subjects with cirrhosis due to hepatitis C virus, only decompensated patients who will not receive antiviral therapy during the study period will be included.
• In subjects with cirrhosis due to autoimmune hepatitis, decompensation must occur in the setting of continuous immunosuppressive therapy.
• Subjects must be willing and able to provide written informed consent or have an authorized representative able to provide written informed consent on behalf of the subject in accordance with local law and institutional policy.

Exclusion Criteria:

• Subjects with ongoing ACLF at Screening,
• Subjects with ongoing HRS or infection or subjects with ongoing or recent bleeding complications (within 2 weeks of Screening).
• Subjects with TIPS or other surgical porto-caval shunts.
• Subjects with an established diagnosis of refractory ascites as defined by ICA criteria.
• Subjects requiring ≥2 large volume paracenteses during the previous 30 days.
• Subjects receiving any dose of anti-platelet therapy or anti-coagulant therapy during the previous 30 days (exception: DVT prophylaxis).
• Subjects with ongoing endoscopic eradication of esophageal varices at discharge.
• Subjects with HE grade III or IV.
• Subjects with evidence of current locally advanced or metastatic malignancy. Subjects with hepatocellular carcinoma within the Milan criteria (1 nodule ≤5 cm or 3 nodules ≤3 cm), non-melanocytic skin cancer, or controlled breast or prostate cancer can be included.
• Subjects with acute or chronic heart failure (New York Heart Association [NYHA]).
• Subjects with severe (grade III or IV) pulmonary disease (Global Obstructive Lung Disease [GOLD]).
• Subjects with serum creatinine >2.0 × upper limit of normal ([ULN] or serum creatinine >2 mg/dL (176 μmol/dL).
• Subjects with organic nephropathy as defined by ICA criteria.
• Subjects with severe psychiatric disorders.
• Subjects with a known infection with human immunodeficiency virus (HIV) or have clinical signs and symptoms consistent with current HIV infection.
• Females who are pregnant, breastfeeding, or if of childbearing potential, unwilling to practice effective methods of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male sterilization, or true abstinence*) throughout the study.
  • * True abstinence: When this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], declaration of abstinence for the duration of the clinical study, and withdrawal are not acceptable methods of contraception).
• Subjects with previous liver transplantation.
• Subjects with known or suspected hypersensitivity to albumin.
• Subjects participating in another clinical study within 3 months prior to screening.
• Aubjects with active drug addiction (exceptions: active alcoholism or marijuana).
• In the opinion of the investigator, the subject may have compliance problems with the protocol and the procedures of the protocol.