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Specific Immunotherapy With Recombinant Birch Pollen Allergen rBet v1-FV

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00266526
First Posted: December 19, 2005
Last Update Posted: March 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
December 16, 2005
December 19, 2005
March 4, 2013
July 2003
July 2004   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00266526 on ClinicalTrials.gov Archive Site
Not Provided
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Specific Immunotherapy With Recombinant Birch Pollen Allergen rBet v1-FV
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
Specific immunotherapy with recombinant birch pollen allergen rBet v1-FV
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Birch Pollen Allergy
Biological: Recombinant birch pollen
Not Provided
Klimek L, Bachert C, Lukat KF, Pfaar O, Meyer H, Narkus A. Allergy immunotherapy with a hypoallergenic recombinant birch pollen allergen rBet v 1-FV in a randomized controlled trial. Clin Transl Allergy. 2015 Aug 3;5:28. doi: 10.1186/s13601-015-0071-x. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
July 2005
July 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00266526
Al0303rB
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Not Provided
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