Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553456
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
Phase IIIII Clinical Trial of Recombinant Human Serum Albumin in Cirrhotic Patients With Ascites
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Random Double-blind Parallel Group Phase IIIII Clinical Trial to Evaluate the Effectiveness and Safety of Recombinant Human Serum Albumin Versus Human Serum Albumin in Hepatic Cirrhosis Patients With Ascites
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial adopts random double-blind positive control parallel group design to evaluate the effectiveness and safety of recombinant human serum albumin versus human serum albumin in hepatic cirrhosis patients with ascites
Detailed Description:
This trial adopts random double-blind positive control parallel group design to evaluate the effectiveness and safety of recombinant human serum albumin versus human serum albumin in hepatic cirrhosis patients with ascites
In this trialphase III the efficacy of rHSA will be evaluated by the change in serum albumin concentration immediately after the last intravenous administration from baseline and its safety PD characteristics and immunogenicity will be further evaluated
In this trialphase III the efficacy of rHSA will be evaluated by the change in serum albumin concentration immediately after the last intravenous administration from baseline and its safety PD characteristics and immunogenicity will be further evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None