Back to resultsSafety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis
Primary Purpose
Birch Pollen Allergy
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Recombinant birch pollen
Sponsored by
About this trial
This is an interventional treatment trial for Birch Pollen Allergy focused on measuring Allergy, Birch pollen, Recombinant
Eligibility Criteria
Inclusion Criteria: Positive Skin Prick Test reaction to birch pollen Positive RAST result to birch pollen Positive Provocation Test result to birch pollen Exclusion Criteria: Serious chronic diseases Other perennial allergies
Sites / Locations
- Allergopharma GmbH & Co. KG
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00309062
First Posted
March 30, 2006
Last Updated
March 8, 2013
Sponsor
Allergopharma GmbH & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT00309062
Brief Title
Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis
Official Title
A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Immunotherapy With an Aluminium Hydroxide-adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen, Bet v 1
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergopharma GmbH & Co. KG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic rhinoconjunctivitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birch Pollen Allergy
Keywords
Allergy, Birch pollen, Recombinant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Recombinant birch pollen
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Positive Skin Prick Test reaction to birch pollen
Positive RAST result to birch pollen
Positive Provocation Test result to birch pollen
Exclusion Criteria:
Serious chronic diseases
Other perennial allergies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annemie Narkus, M D
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergopharma GmbH & Co. KG
City
Reinbek
ZIP/Postal Code
21465
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.allergopharma.de
Description
Leader in specific allergy research and therapy
Learn more about this trial
Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis
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