Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004286
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase III Multicenter Double Blind Controlled Trial of Human Immune Globulin Therapy in Previously Untreated Patients With Chronic Inflammatory Demyelinating Neuropathy
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-01
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 and evaluate the response to treatment with intravenous human immune globulin IVIG or placebo in previously untreated patients with chronic inflammatory demyelinating polyneuropathy
I Compare and evaluate the response to treatment with intravenous human immune globulin IVIG or placebo in previously untreated patients with chronic inflammatory demyelinating polyneuropathy
Detailed Description:
PROTOCOL OUTLINE This is a double blind randomized controlled study Patients receive either intravenous human immune globulin IVIG or placebo infused at a rate of 40 mLhr increasing every 30 min to a maximum of 100 mLhr daily over 6 to 8 hours for 2 days On day 2 infusions of IVIG or placebo are delivered at the highest dose tolerated on day 1
On day 21 patients receive another IVIG or placebo infusion Following day 42 patients may choose to continue infusions of IVIG every 21 days for 2 doses
Patients not receiving additional treatment are released from study Patients are evaluated on days 10 21 and 43
On day 21 patients receive another IVIG or placebo infusion Following day 42 patients may choose to continue infusions of IVIG every 21 days for 2 doses
Patients not receiving additional treatment are released from study Patients are evaluated on days 10 21 and 43
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 |
|---|---|---|---|
| UVT-535 | None | None | None |