A Phase II Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites
Status:
Recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
Summary
The study is designed to study the efficacy of IV OsrHSA or positive control HSA (10 g and 20
g IV everyday) for 14 days. After a screening period of up to 14 days, the eligible subjects
will be randomized in a 4:1 ratio to OsrHSA and positive control HSA, respectively, in each
cohort. Each enrolled subject will receive multiple assigned doses of OsrHSA. The
Investigator and subjects will be blind to treatment assignment (OsrHSA or positive control
HSA) in each cohort. During the study, subjects will be evaluated for efficacy, safety,
tolerability, and immunogenicity. In each cohort, subjects will be stratified by baseline
serum albumin level. If serum albumin reaches 35 g/L or more, the study drug or control drug
administration may be terminated early. Subjects will have 3 follow-up visits in 2 weeks.