Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04835480
Status:
RECRUITING
Last Update Posted:
2021-11-19
First Post:
2021-04-05
Brief Title:
A Phase II Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites
Sponsor:
Healthgen Biotechnology Corp
Organization:
Healthgen Biotechnology Corp
Study Overview
Official Title:
A Phase II Multicenter Randomized Positive-Controlled and Multi-Cohort Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites
Status:
RECRUITING
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 41 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 gL or more the study drug or control drug administration may be terminated early Subjects will have 3 follow-up visits in 2 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None