Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 8:07 PM
Study NCT ID:
NCT00712933
Status:
COMPLETED
Last Update Posted:
2019-12-05
First Post:
2008-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057
Sponsor:
Human Genome Sciences Inc., a GSK Company
Organization:
Study Overview
Official Title:
A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™)a Fully Human Monoclonal Anti-BLyS Antibody in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057
Status:
COMPLETED
Status Verified Date:
2019-11
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:
This is a long-term continuation study to provide continuing treatment to subjects with SLE.
Detailed Description:
This trial is a long-term continuation study to provide continuing treatment to subjects with System Lupus Erythematosus (SLE).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|---|
| 2007-007648-85 | EUDRACT_NUMBER | None | View |