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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 09, 2014