Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004682
Status:
TERMINATED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Randomized Study of Intravenous Immunoglobulin in Patients With Mild or Moderate Myasthenia Gravis
Sponsor:
University of Texas
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
1999-03
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:
OBJECTIVES
I Determine whether intravenous immunoglobulin is an effective therapy for patients with mild or moderate myasthenia gravis
I Determine whether intravenous immunoglobulin is an effective therapy for patients with mild or moderate myasthenia gravis
Detailed Description:
PROTOCOL OUTLINE This study is a randomized blinded controlled study Patients are stratified in both groups according to prior thymectomy yes vs no and by Quantitative Myasthenia Gravis Score equal to or less than 10 vs greater than 10 so that equal numbers are assigned to each group Patients in group 2 are also stratified as to whether they are currently on azathioprine
Patients are randomized to receive either intravenous immunoglobulin IVIG for 2 days or 5 albumin the placebo for 2 days A second infusion of IVIG for 1 day or albumin placebo for 1 day is given on day 22
At the end of 6 weeks after the randomized study patients may choose to receive 3 additional IVIG infusions
Patients are followed on days 1 21 32 and 42 of randomized or open label study
Completion date provided represents the completion date of the grant per OOPD records
Patients are randomized to receive either intravenous immunoglobulin IVIG for 2 days or 5 albumin the placebo for 2 days A second infusion of IVIG for 1 day or albumin placebo for 1 day is given on day 22
At the end of 6 weeks after the randomized study patients may choose to receive 3 additional IVIG infusions
Patients are followed on days 1 21 32 and 42 of randomized or open label study
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 |
|---|---|---|---|
| UTSMC-039509700 | None | None | None |
| UTSMC-FDR001362 | None | None | None |