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Specific Immunotherapy With Recombinant Birch Pollen Allergen rBet v1-FV
This study is ongoing, but not recruiting participants.
First Received: December 16, 2005   Last Updated: July 16, 2008   History of Changes
Sponsored by: Allergopharma Joachim Ganzer KG
Information provided by: Allergopharma Joachim Ganzer KG
ClinicalTrials.gov Identifier: NCT00266526
  Purpose

Specific immunotherapy with recombinant birch pollen allergen rBet v1-FV


Condition Intervention Phase
Birch Pollen Allergy
Biological: Recombinant birch pollen
Phase II

MedlinePlus related topics: Allergy Hay Fever
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Bicentre Open Label Randomised Pilot Study for Proof of Safety and Efficacy of Immunotherapy With an Aluminium Hydroxide-Adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen Bet v 1-FV Versus a Depot Extract of Natural Birch Allergen

Further study details as provided by Allergopharma Joachim Ganzer KG:

Study Start Date: July 2003
Estimated Study Completion Date: July 2004
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive RAST result to birch pollen
  • Positive Skin Prick Test reaction to birch pollen
  • positive nasal provocation test result to birch pollen extract

Exclusion Criteria:

  • serious chronic diseases
  • other relevant seasonal allergies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266526

Locations
Germany
Allergopharma Joachim Ganzer KG
Reinbek, Germany, 21465
Sponsors and Collaborators
Allergopharma Joachim Ganzer KG
Investigators
Principal Investigator: Annemie Narkus, M.D. unaffiliated
  More Information

Additional Information:
No publications provided

Study ID Numbers: Al0303rB
Study First Received: December 16, 2005
Last Updated: July 16, 2008
ClinicalTrials.gov Identifier: NCT00266526     History of Changes
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Allergopharma Joachim Ganzer KG:
Allergy
Birch pollen
Recombinant

Study placed in the following topic categories:
Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Rhinitis
Aluminum Hydroxide
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Hypersensitivity
Otorhinolaryngologic Diseases
Immune System Diseases
Respiratory Tract Diseases
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Rhinitis
Nose Diseases
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009