A Trial of Grazax in Subjects With Hayfever

Phase 3

Completed

• Conditions: Allergy
• Interventions: Drug: Grazax

• Registration Number: NCT00421655
• Lead Sponsor: ALK-Abelló A/S

Brief Summary

The trial is performed to evaluate the efficacy and safety of specific immunotherapy with Grazax for treatment of grass pollen induced allergy.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-01-11
• Study First Submitted QC: 2007-01-11
• Study First Posted: 2007-01-12
• Primary Completion: 2007-08
• Study Completion: 2007-10
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-23
• Last Update Posted: 2015-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 329

Inclusion Criteria

• History of grass pollen allergy
• Positive skin prick test to grass
• Positive specific IgE to grass

Exclusion Criteria

• FEV1 <70% of predicted value

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Grazax	-
2	Grazax	-

Primary Outcome Measures

Name	Time	Method
Recording of allergy symptoms	Grass pollen season 2007

Trial Locations

Locations (1)

CompleWare Corporation; 🇺🇸 Iowa City, Iowa, United States