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 enrollmentMay 14, 2018

Overview

No summary available.

Registry

who.int

Start Date

May 14, 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.
•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
•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

•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\. Subject with refractory ascites as defined by ICA criteria without any other event of acute decompensation (Appendix 2\).
•5v5\. This criterion has been removed from 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.
•8v5\. This criterion has been removed from protocol Version 5\.
•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] \[Appendix 6], non\-melanocytic skin cancer, or controlled breast or prostate cancer can be included.
•10v4\. Subjects with acute or chronic heart failure (New York Heart Association \[NYHA] Appendix 7\).