Specific Immunotherapy With Recombinant Birch Pollen Allergen rBet v1-FV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00266526
First received: December 16, 2005
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

Specific immunotherapy with recombinant birch pollen allergen rBet v1-FV


Condition Intervention Phase
Birch Pollen Allergy
Biological: Recombinant birch pollen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Allergopharma GmbH & Co. KG:

Study Start Date: July 2003
Study Completion Date: July 2005
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
  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 GmbH & Co. KG
Reinbek, Germany, 21465
Sponsors and Collaborators
Allergopharma GmbH & Co. KG
Investigators
Principal Investigator: Annemie Narkus, M.D.
  More Information

Additional Information:
No publications provided

Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00266526     History of Changes
Other Study ID Numbers: Al0303rB
Study First Received: December 16, 2005
Last Updated: March 1, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Allergopharma GmbH & Co. KG:
Allergy
Birch pollen
Recombinant

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

ClinicalTrials.gov processed this record on April 17, 2014