Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312475
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-12-30
Brief Title:
Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B With Inhibitors
Sponsor:
Suzhou Alphamab Co Ltd
Organization:
Suzhou Alphamab Co Ltd
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 With Inhibitors
Status:
RECRUITING
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:
The purpose of this study is to show that KN057 can prevent bleeds in patients with haemophilia A or B with inhibitors and is safe to use Successfully screened participants will be randomly assigned to KN057 Prophylaxis Arm 1 versus No Prophylaxis Arm 2 at a ratio of 21 Participants in KN057 Prophylaxis will receive KN057 prophylaxis for 52 weeks upon enrollment Participants in No Prophylaxis will first receive on-demand treatment for 26 weeks then switch to KN057 prophylaxis for 26 weeksThe trial period is 59 weeks including a 3-week screening period a 26-week main trial a 26-week extension period and a 4-week follow-up period after the last administration
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