Data from clinicaltrials.gov - Curated by EPG Health - Last updated 18 March 2019

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...

purpose

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.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 410 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Mortality With Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites
Actual Study Start Date: July 24, 2018
Estimated Primary Completion Date: October 2021
Estimated Study Completion Date: October 2021

Arms:
- Experimental:
SMT + Albutein 20%
- Active Comparator: SMT

Category Value
Date last updated at source 13-Mar-19
Study type(s) Interventional
Expected enrolment 410
Study start date 24-Jul-18
Estimated primary completion date 01-Oct-21
Supplementary ID IG1601

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