Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04864743
Status:
COMPLETED
Last Update Posted:
2023-09-08
First Post:
2021-04-21
Brief Title:
A Study to Evaluate the PharmacokineticsSafety and Tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
Sponsor:
Jiangsu Gensciences lnc
Organization:
Jiangsu Gensciences lnc
Study Overview
Official Title:
An Open-Label Multicenter Evaluation of the PharmacokineticsSafety and Tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection FRSW117 in Patients With Severe Hemophilia A
Status:
COMPLETED
Status Verified Date:
2023-05
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 primary objectives of the study are to evaluate the PharmacokineticsSafety and tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection FRSW117 in patients with severe hemophilia A
The secondary objectives are to monitor anti-durg antibodies and anti-PEG antibodies levels in patients with severe hemophilia A
The secondary objectives are to monitor anti-durg antibodies and anti-PEG antibodies levels in patients with severe hemophilia A
Detailed Description:
None
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