Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569108
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-12-30
Brief Title:
Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B Without Inhibitors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Open-label Study to Evaluate the Efficacy and Safety of KN057 Injection Prophylaxis in Patients With Hemophilia A or B Without Inhibitors
Status:
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:
The purpose of this study is to show that KN057 can prevent bleeds in patients with haemophilia A or B without inhibitors and is safe to use Participants receiving on-demand treatment prior to screening will be randomly assigned to Experimental group or Control group at a ratio of 21 in Part A Participants receiving prophylaxis prior to screening will be nonrandomly assigned to Prophylaxis group in Part B Participants in Experimental group will receive KN057 prophylaxis for 52 weeks upon enrollment Participants in Control group will first receive on-demand treatment for 26 weeks then switch to KN057 prophylaxis for 26 weeks Participants in Prophylaxis group will first receive prophylaxis with coagulation factor for 26 weeks then switch to KN057 prophylaxis for 26 weeks
Detailed Description:
None
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