Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298955
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-17
Brief Title:
Long-Term Safety Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria
Sponsor:
Omeros Corporation
Organization:
Omeros Corporation
Study Overview
Official Title:
An Open-Label Study to Evaluate the Long-Term Safety Tolerability and Efficacy of OMS906 in Patients With Paroxysmal Nocturnal Hemoglobinuria PNH
Status:
RECRUITING
Status Verified Date:
2024-02
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 assess the long-term safety and tolerability of repeat-dose OMS906 5 mgkg IV administration at 8-week intervals in patients with PNH
Detailed Description:
This is a multicenter open-label single arm study The primary objective is to assess the long-term safety and tolerability of OMS906 in patients with PNH Secondary objectives of this study include assessment of the long-term efficacy of OMS906 in patients with PNH Patients will receive OMS906 5 mgkg administered as intravenous IV injections at 8-week intervals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None