Effects of Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites
Effects of Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites
This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label
 clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20%
 administration versus SMT alone in subjects with decompensated cirrhosis and ascites. The
 study population will consist of subjects being discharged after hospitalization for acute
 decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring
 diuretic therapy) with or without acute-on-chronic liver failure (ACLF) at admission or
 during hospitalization but without ACLF at discharge.
Inclusion Criteria:

 -  Subjects with diagnosis of liver cirrhosis and uncomplicated ascites according to the
 ICA criteria

 -  Subjects being discharged after hospitalization 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
 discharge

 -  Subjects with ongoing diuretic treatment with an anti-mineralocorticoid drug at a dose
 of ≥100 mg/day and furosemide ≥40 mg/day independent of response to treatment

 -  In subjects with cirrhosis due to hepatitis B virus, decompensation must occur in the
 setting of continuous (not <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

 Exclusion Criteria:

 -  Subjects with ongoing ACLF at discharge

 -  Subjects with ongoing or recent (within the last 30 days) hepatorenal syndrome (HRS),
 infection, or bleeding complications

 -  Subjects with transjugular intrahepatic portosystemic shunt (TIPS) or other surgical
 porto-caval shunts

 -  Subjects with an established diagnosis of refractory ascites as defined by ICA
 criteria

 -  Subjects requiring ≥2 paracenteses during the previous 30 days

 -  Subjects receiving anti-platelet therapy or anti-coagulant therapy during the previous
 30 days

 -  Subjects with ongoing endoscopic eradication of esophageal varices at discharge

 -  Subjects with hepatic encephalopathy grade III or IV

 -  Subjects with evidence of current locally advanced or metastatic malignancy. Subjects
 with hepatocellular carcinoma within the Milan criteria, non-melanocytic skin cancer,
 or controlled breast or prostate cancer can be included

 -  Subjects with chronic heart failure

 -  Subjects with severe (grade III or IV) pulmonary disease

 -  Subjects with serum creatinine >2.0 x upper limit of normal

 -  Subjects with organic nephropathy as defined by ICA criteria

 -  Subjects with sever 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 a highly effective method of contraception throughout the study

 -  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

 -  Subjects with active drug addiction