Ignite Creation Date:
2024-05-06 @ 10:15 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03205995
Status:
RECRUITING
Last Update Posted:
2018-10-18
First Post:
2017-04-17
Brief Title:
Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic Syndrome
Sponsor:
Omeros Corporation
Organization:
Omeros Corporation
Study Overview
Official Title:
A Phase 3 Study to Evaluate the Safety and Efficacy of OMS721 for the Treatment of Atypical Hemolytic Uremic Syndrome aHUS in Adults and Adolescents
Status:
RECRUITING
Status Verified Date:
2018-10
Last Known Status:
Recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT02355782
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
aHUS
Brief Summary:
The purpose of this study is to evaluate the platelet count change from baseline and safety of OMS721 in adults and adolescents with atypical hemolytic uremic syndrome aHUS The study will also evaluate pharmacokinetics PK pharmacodynamics PD and anti-drug antibody response ADA
Detailed Description:
This is a Phase 3 multicenter study of OMS721 in adults and adolescents with atypical hemolytic uremic syndrome aHUS The uncontrolled open-label study will evaluate the effect of OMS721 in subjects with plasma therapy-resistant aHUS and plasma therapy-responsive aHUS This study has four periods Screening Treatment Induction Treatment Maintenance and Follow-up Approximate enrollment is 80 subjects An interim analysis will be performed after 40 subjects have completed 26 weeks of treatment for potential registration
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?:
None
Is an FDA AA801 Violation?:
None