A Phase II Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites

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.

Timeline

Start

2021-03-22

Primary completion

2022-06-30

Completion

2022-06-30

Outcome

Met primary endpoint

paper Primary outcome of OsrHSA (130/171, 76%) was non-inferior to pHSA (34/45, 75.6%) (difference=0.5%; lower limit of 97.5% CI=-0.119). PMID 40555465 ↗

Publications

• Niu J, Gao Y, Wang G, Qin Z, Wu C, Yu Z, Wang L, Hu Z, Li X, Zhang Z, Chen Y, Yao L, Yang J, Li GM, Yang Y, Lu X, Gu Y, Wu X, Mao X, Zhou Z, Shang J, Lin B, Jia JD, Wang F, Zhang J, Ma H, Wang X, Yang CY, Yang D. Rice-derived recombinant human serum albumin as an alternative to human plasma for patients with decompensated liver cirrhosis: a randomised, double-blind, positive-controlled and non-inferiority trial. Gut. 2025 Aug 7;74(9):1476-1485. doi: 10.1136/gutjnl-2025-335577.

Drugs

Indications