Ignite Creation Date:
2025-12-17 @ 4:29 PM
Ignite Modification Date:
2025-12-24 @ 1:47 AM
Study NCT ID:
NCT00724867
Status:
COMPLETED
Last Update Posted:
2016-03-28
First Post:
2008-07-28
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States
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 in the United States
Status:
COMPLETED
Status Verified Date:
2016-03
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 continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of belimumab(LymphoStat-B™) in subjects with SLE disease.
Detailed Description:
This is a long-term continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States. This study is to evaluate the long-term safety and efficacy of belimumab (LymphoStat-B™) in subjects with SLE disease.
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 |
|---|---|---|---|---|
| HGS1006-C1066 | OTHER | Human Genome Sciences | View |