Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 6:40 PM
Study NCT ID:
NCT01059266
Status:
COMPLETED
Last Update Posted:
2012-02-10
First Post:
2010-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PURETHAL Grasses Rush Study
Sponsor:
HAL Allergy
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Open, Multi-centre Study to Assess Safety of PURETHAL Grasses Given With a Rush Induction Schedule to Patients With Allergic Rhinoconjunctivitis
Status:
COMPLETED
Status Verified Date:
2012-02
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:
None
Brief Summary:
This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Grasses will be evaluated in a rush regimen (maximum dose reached in 3 injections during 2 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 5 weeks).
The primary parameter will be the proportion of patients who experience systemic reactions \> grade I within 24 hours after injection or who need more than 2 additional injections during the up-dosing phase until the maintenance dose has been reached.
It is expected that up-dosing PURETHAL Grasses according to the rush regimen is as safe as using the conventional regimen.
The primary parameter will be the proportion of patients who experience systemic reactions \> grade I within 24 hours after injection or who need more than 2 additional injections during the up-dosing phase until the maintenance dose has been reached.
It is expected that up-dosing PURETHAL Grasses according to the rush regimen is as safe as using the conventional regimen.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: