Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355479
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2024-03-21
Brief Title:
A Study to Evaluate the Efficacy and Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia
Sponsor:
Healthgen Biotechnology Corp
Organization:
Healthgen Biotechnology Corp
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Active-controlled Multi-center Study to Evaluate the Efficacy Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia
Status:
COMPLETED
Status Verified Date:
2024-04
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 goal of this clinical trial is to evaluate the efficacy of OsrHSA works to treat hypoalbuminemia in hepatic cirrhosis patients It will also learn about the safety and immunogenicity of OsrHSA The main question it aims to answer is whether OsrHSA is effective in elevating the serum albumin level of cirrhotic patients with hypoalbuminemia
Researchers will compare OsrHSA to the positive comparator plasma-derived HSA pHSA to see if OsrHSA presents as non-inferior to pHSA in the indication of hypoalbuminemia in hepatic cirrhosis patients
Participants will be randomized in a 11 ratio to receive OsrHSA or HpHSA 20g IV qd for up to 14 days following an EOT visit Follow-up visits will be taken on EOT7d EOT14d and EOT30d respectively
Researchers will compare OsrHSA to the positive comparator plasma-derived HSA pHSA to see if OsrHSA presents as non-inferior to pHSA in the indication of hypoalbuminemia in hepatic cirrhosis patients
Participants will be randomized in a 11 ratio to receive OsrHSA or HpHSA 20g IV qd for up to 14 days following an EOT visit Follow-up visits will be taken on EOT7d EOT14d and EOT30d respectively
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?:
False
Is an FDA AA801 Violation?:
None