Viewing Study NCT00004286



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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
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

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