Intraseasonal Short-Time up-Dosing With Alutard SQ Grasses - Full Text View

Sponsored by:	ALK-Abelló A/S
Information provided by:	ALK-Abelló A/S
ClinicalTrials.gov Identifier:	NCT00807547

Purpose

Test of pharmacodynamic efficacy and tolerability of a short-time itra-seasonal updosing

Condition	Intervention	Phase
Allergy	Biological: allergy vaccination (Alutard SQ)	Phase III

MedlinePlus related topics: Allergy

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	A Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Multicentre Phase III Trial Assessing the Pharmacodynamic Efficacy and Safety of an Intra-Seasonal Short-Time Updosing Schedule for Alutard SQ

Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:

Changes from baseline in IgE-blocking factor [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Estimated Enrollment:	144
Study Start Date:	May 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Alutard SQ grasses and rye, 8 subcutaneous injections, updosing to 10.000 SQ-U, duration of treatment 50 days

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	ALK-Abello Arzneimittel GmbH, Wedel, Germany ( Hendrik Wolf/Senior Manager Clinical Development )
Study ID Numbers:	SHX0562
Study First Received:	September 30, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00807547
Health Authority:	Germany: Paul-Ehrlich-Institut

Study placed in the following topic categories:

Hypersensitivity

ClinicalTrials.gov processed this record on January 16, 2009