Ignite Creation Date:
2024-05-05 @ 10:41 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01166269
Status:
COMPLETED
Last Update Posted:
2012-11-08
First Post:
2010-07-20
Brief Title:
Study to Asses Efficacy of Intralymphatic Immunotherapy
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Intralymphatic Specific Immunotherapy - as a New Treatment Form for Grass-pollen Allergic Subjects
Status:
COMPLETED
Status Verified Date:
2012-11
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:
ILIT
Brief Summary:
The purpose of the study is to try a new route for specific immunotherapy SIT The current treatment form for SIT is subcutaneously SCIT which is a long treatment with up to 50 injections subcutaneously in the upper arm
The investigators believe that there is additional effect if the allergen is injected directly into the lymph node since it is here the allergen presentation is happening The trial has been performed in Switzerland with significant effect of only three injections of grass-allergen into a lymph node Clinicaltrialsgov NCT00470457
The investigators would like to see what happens if the the dose is doubled so the patients will receive 6 injections all in all with the same amount of allergen as the earlier study 1000 SQ-U Also the outcome measurements is slightly different as the patients will note their symptoms in a diary
The patients will be divided into three groups using allocation
1 group with 6 injections of allergen
1 group with 3 injections of allergen and 3 injections of placebo
1 group with 6 injections of placebo The trial will be double blinded
The investigators believe that there is additional effect if the allergen is injected directly into the lymph node since it is here the allergen presentation is happening The trial has been performed in Switzerland with significant effect of only three injections of grass-allergen into a lymph node Clinicaltrialsgov NCT00470457
The investigators would like to see what happens if the the dose is doubled so the patients will receive 6 injections all in all with the same amount of allergen as the earlier study 1000 SQ-U Also the outcome measurements is slightly different as the patients will note their symptoms in a diary
The patients will be divided into three groups using allocation
1 group with 6 injections of allergen
1 group with 3 injections of allergen and 3 injections of placebo
1 group with 6 injections of placebo The trial will be double blinded
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