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

Instituto Grifols S.A.0 sites410 target enrollmentMarch 22, 2018

Overview

No summary available.

Registry

who.int

Start Date

March 22, 2018

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Male or female subject \=18 years of age.
•2\. 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.
•3\. 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.
•4\. 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.
•5\. In subjects with cirrhosis due to HBV, decompensation must occur in the setting of continuous (not \<3 months) appropriate antiviral therapy.
•6\. In subjects with cirrhosis due to HCV, only decompensated patients who will not receive antiviral therapy during the study period will be included.
•7\. In subjects with cirrhosis due to autoimmune hepatitis, decompensation must occur in the setting of continuous immunosuppressive therapy.
•8\. 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\. Subjects with ongoing ACLF at discharge.
•2\. Subjects with ongoing or recent (within the last 30 days) HRS, infection, or bleeding complications.
•3\. Subjects with TIPS or other surgical porto\-caval shunts.
•4\. Subject with an established diagnosis of refractory ascites as defined by ICA criteria.
•5\. Subjects requiring \=2 paracenteses during the previous 30 days.
•6\. Subjects receiving anti\-platelet therapy or anti\-coagulant therapy during the previous 30 days.
•7\. Subjects with ongoing endoscopic eradication of esophageal varices at discharge.
•8\. Subjects with HE grade III or IV.
•9\. 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.
•10\. Subjects with chronic heart failure (New York Heart Association \[NYHA]).