Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06134414
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-22
First Post:
2023-11-10
Brief Title:
Study of Safety and Efficacy of MY008211A in in Patients With Paroxysmal Nocturnal Hemoglobinuria PNH
Sponsor:
Wuhan Createrna Science and Technology Co Ltd
Organization:
Wuhan Createrna Science and Technology Co Ltd
Study Overview
Official Title:
A Multi-center Randomized Parallel Open-label Clinical Phase II Study to Evaluate the Efficacy and Safety of MY008211A in Adult Paroxysmal Nocturnal Hemoglobinuria PNH Patients With Signs of Active Hemolysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
The main purpose of this study is to evaluate the efficacy of MY008211A in adult patients with PNH showing signs of active hemolysis
Detailed Description:
The purpose of this study is to determine whether MY008211A is efficacious and safe for the treatment of PNH patients who are naïve to complement inhibitor therapy including anti-C5 antibody
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