Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05889299
Status:
RECRUITING
Last Update Posted:
2023-06-05
First Post:
2023-05-04
Brief Title:
Study of the Safety and Efficacy of OMS906 in Patients With Paroxysmal Nocturnal Hemoglobinuria
Sponsor:
Omeros Corporation
Organization:
Omeros Corporation
Study Overview
Official Title:
A Phase 1b Proof of Concept Study to Evaluate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Efficacy of OMS906 in Patients With Paroxysmal Nocturnal Hemoglobinuria
Status:
RECRUITING
Status Verified Date:
2023-05
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 safety tolerability pharmacokinetics pharmacodynamics and preliminary efficacy in patients with Paroxysmal Nocturnal Hemoglobinuria PNH
Detailed Description:
This is a Phase 1b proof of concept open-label uncontrolled fixed-dose study The primary objective is to assess safety and tolerability of OMS906 in patients with PNH Patients will receive 5 mgkg OMS906 administered as subcutaneous SC injections at 4-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