Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-03-04 @ 10:24 PM
Study NCT ID:
NCT01691859
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2012-09-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MEA112997 Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
MEA115666: A Multi-centre, Open-label, Long Term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in the MEA112997 Trial
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT00244686
Has Expanded Access, NCT# Status:
NO_LONGER_AVAILABLE
Acronym:
None
Brief Summary:
This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab administered subcutaneously (SC) in addition to standard of care in subjects who participated in the MEA112997 study. At each clinic visit, adverse events will be assessed and exacerbations will also be reviewed.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-001643-51 | EUDRACT_NUMBER | None | View |