Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399289
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-05-01
Brief Title:
Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin rIX-FP in Chinese Subjects With Hemophilia B Previously Treated With FIX Therapy
Sponsor:
CSL Behring
Organization:
CSL Behring
Study Overview
Official Title:
A Phase 3 Open-label Multicenter Pharmacokinetics Efficacy and Safety Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin rIX-FP in Previously Treated Chinese Subjects With Hemophilia B
Status:
RECRUITING
Status Verified Date:
2024-10
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 will investigate the pharmacokinetics PK efficacy and safety of rIX-FP for the routine prophylaxis of bleeding episodes in male Chinese previously treated patients PTPs with hemophilia B FIX activity of 2 In addition to the scheduled rIX-FP prophylaxis regimen subjects may also receive rIX-FP episodic on-demand treatment for breakthrough bleeding episodes and rIX-FP for the prophylaxis and treatment of bleeding in emergency surgical procedures
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-002333-34 | EUDRACT_NUMBER | None | None |