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RECRUITING
NCT04835480
PHASE2

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

Sponsor: Healthgen Biotechnology Corp.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2021-03-22

Completion Date

2022-06-30

Last Updated

2021-11-19

Healthy Volunteers

No

Interventions

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)

Locations (1)

First Hospital of Jilin University

Changchun, Jilin, China