Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411743
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2024-03-29
Brief Title:
Phase IIIII of Recombinant Human Albumin Injection
Sponsor:
The First Hospital of Jilin University
Organization:
The First Hospital of Jilin University
Study Overview
Official Title:
A Phase IIIII Clinical Study of Recombinant Human Albumin Injection for the Treatment of Hypoalbuminemia in Cirrhotic Patients With Ascites
Status:
COMPLETED
Status Verified Date:
2024-03
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:
This study was a Phase IIIII multicenter blinded and positiveactive-controlled clinical study with seamless adaptive design to evaluate the dose-response relationship safety and immunogenicity of recombinant human albuminrHA injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites and to provide a reference for the design of the Phase III clinical study
Detailed Description:
This study was a Phase IIIII multicenter blinded and positive-controlled clinical study with seamless adaptive design The Phase II clinical study was conducted first followed by the Phase III clinical studyThe Phase II clinical study aimed to evaluate the dose-response relationship safety and immunogenicity of recombinant human albuminrHA injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites and provide a reference for the design of Phase III clinical study Dosage For the 10 gday rHA injection group the subjects were administered rHA at a dose of 10 gday once daily for 14 days For the 20 gday rHA injection group the subjects were administered rHA at a dose of 20 gday once daily for 7 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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