Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004833
Status:
TERMINATED
Last Update Posted:
2015-04-07
First Post:
2000-02-24
Brief Title:
Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome
Sponsor:
Emory University
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2002-09
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:
OBJECTIVES
I Compare the efficacy of plasmapheresis and human immunoglobulin infusion in minimizing morbidity and augmenting the pace of recovery in children with Guillain-Barre syndrome
II Compare the potential risks in terms of treatment related side effects and adverse clinical outcome between these two treatment modalities
I Compare the efficacy of plasmapheresis and human immunoglobulin infusion in minimizing morbidity and augmenting the pace of recovery in children with Guillain-Barre syndrome
II Compare the potential risks in terms of treatment related side effects and adverse clinical outcome between these two treatment modalities
Detailed Description:
PROTOCOL OUTLINE
This is a randomized multicenter study
Patients are randomized to receive either human immunoglobulin infusion IVIg arm I or plasmapheresis arm II
Arm I patients receive liquid heat-treated IVIg for 4 days starting on day 1 and then another single infusion of IVIg on day 7 8 or 9
Arm II patients receive serial plasmapheresis treatments The first exchange is given on day 1 and the remaining exchanges are given over the next 5-10 days
Patients are followed at weeks 1 2 3 4 8 12 and 24
Completion date provided represents the completion date of the grant per OOPD records
This is a randomized multicenter study
Patients are randomized to receive either human immunoglobulin infusion IVIg arm I or plasmapheresis arm II
Arm I patients receive liquid heat-treated IVIg for 4 days starting on day 1 and then another single infusion of IVIg on day 7 8 or 9
Arm II patients receive serial plasmapheresis treatments The first exchange is given on day 1 and the remaining exchanges are given over the next 5-10 days
Patients are followed at weeks 1 2 3 4 8 12 and 24
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUSM-FDR001265 | None | None | None |
| EUSM-076-97 | None | None | None |