Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220740
Status:
COMPLETED
Last Update Posted:
2016-03-23
First Post:
2005-09-13
Brief Title:
Immune Globulin Intravenous IGIV For Chronic Inflammatory Demyelinating Polyneuropathy CIDP
Sponsor:
Grifols Therapeutics LLC
Organization:
Grifols Therapeutics LLC
Study Overview
Official Title:
Multicenter Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of IGIV-Chromatography IGIV-C 10 Treatment in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy
Status:
COMPLETED
Status Verified Date:
2016-02
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:
ICE
Brief Summary:
The intent of this study is to demonstrate the efficacy and safety of Immune Globulin Intravenous Human 10 CaprylateChromatography Purified IGIV-C in newly or previously diagnosed CIDP subjects Eight courses of treatment with either placebo or IGIV-C will occur every 3 weeks Neurological function will be measured by Inflammatory Neuropathy Cause and Treatment INCAT scores Patients who deteriorate or show no improvement between day 16 and month 6 will receive the alternate study drug for an additional 6 months
Detailed Description:
110 subjects 55 per treatment group with newly or previously diagnosed CIDP defined by INCAT neurophysiological diagnostic criteria will be enrolled into the trial Patients will not be replaced if they discontinue prematurely
Study Oversight
Has Oversight DMC:
None
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?:
None