Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413556
Status:
COMPLETED
Last Update Posted:
2008-03-06
First Post:
2006-12-18
Brief Title:
Changes in the Immune Response and Skin Reactivity of Grass Pollen Allergic Patients Treated With ALK Grass Tablets
Sponsor:
ALK-Abelló AS
Organization:
ALK-Abelló AS
Study Overview
Official Title:
Randomised Double-Blind Placebo-Controlled Phase IIIb Study Investigating Changes in Immunological Parameters and Cutaneous Reactivity Induced by a Short Course Immunotherapy With ALK Grass Tablets
Status:
COMPLETED
Status Verified Date:
2008-03
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:
We plan to determine changes in the immune system during the allergic response to grass pollen allergens We have chosen a particular element of the immune response the immunoglobulin G4 IgG4 as an indicator
We hypothesize that treatment with Grazax will increase serum levels of Phleum pratense specific IgG4 and IgE as well as reduce the cutaneous sensitivity of the early IgE mediated and late cell mediated allergic response
We hypothesize that treatment with Grazax will increase serum levels of Phleum pratense specific IgG4 and IgE as well as reduce the cutaneous sensitivity of the early IgE mediated and late cell mediated allergic response
Detailed Description:
None
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