Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

Summary

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.

Official Title

Prevention of Mortality With Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites

Keywords

Decompensated Cirrhosis and Ascites Fibrosis Liver Cirrhosis Ascites Albutein 20% Injectable Solution SMT + Albutein 20% SMT

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • Southern California Research Center accepting new patients
    Coronado California 92118 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Grifols Therapeutics LLC
ID
NCT03451292
Phase
Phase 3
Study Type
Interventional
Last Updated