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 31, 2022

Overview

No summary available.

Registry

who.int

Start Date

March 31, 2022

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.
•2v5\. Subjects with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology).
•3v5\. Subjects who have been hospitalized 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.
•4v5\. This criterion has been removed from Version 5 of the protocol.
•5\. In subjects with cirrhosis due to HBV, decompensation must occur in the setting of continuous (no less than 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 (subjects receiving antiviral therapy within 14 days prior to enrollment cannot be included in the study).
•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.
•9v5\. CLIF\-C AD score \> 50 points at screening.
•Are the trial subjects under 18? no

•1v5\. Subjects with ACLF at Screening
•2v5\. Subjects with type 1 HRS currently on treatment with vasoconstrictors or hemodialysis.
•3\. Subjects with TIPS or other surgical porto\-caval shunts.
•4v5\. Subjects with refractory ascites as defined by ICA criteria without any other event of
•acute decompensation.
•5v5\. This criterion has been removed in protocol Version 5\.
•6v5\. Subjects receiving dual anti\-platelet therapy or anti\-coagulant therapy (exception:
•DVT prophylaxis).
•7v5\. Subjects with ongoing endoscopic eradication of esophageal varices with \= 2
•endoscopic sessions completed before screening.