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Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00309062
First received: March 30, 2006
Last updated: March 8, 2013
Last verified: March 2013
March 30, 2006
March 8, 2013
December 2003
June 2006   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00309062 on ClinicalTrials.gov Archive Site
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Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis
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
Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic rhinoconjunctivitis
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Birch Pollen Allergy
Biological: Recombinant birch pollen
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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June 2009
June 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00309062
Al0103rB
No
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Allergopharma GmbH & Co. KG
Allergopharma GmbH & Co. KG
Not Provided
Principal Investigator: Annemie Narkus, M D
Allergopharma GmbH & Co. KG
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP