NCT04835480

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

A Phase II, Multicenter, Randomized, Positive-Controlled, and Multi-Cohort Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Healthgen Biotechnology Corp. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cirrhotic Ascites

Interventions

Type	Name	Description
DRUG	OrsHSA	OsrHSA a recombinant HSA, which was expressed and purified from the plant Oryza sativa
DRUG	HSA	Albutein® 20% (ALBUMIN HUMAN INFUSION 20% 50ML)

Timeline

• Start date: 2021-03-22
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2021-04-08
• Last updated: 2021-11-19

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study