Back to resultsSpecific Immunotherapy With Recombinant Birch Pollen Allergen rBet v1-FV
Primary Purpose
Birch Pollen Allergy
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Recombinant birch pollen
Sponsored by
About this trial
This is an interventional treatment trial for Birch Pollen Allergy focused on measuring Allergy, Birch pollen, Recombinant
Eligibility 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
Sites / Locations
- Allergopharma GmbH & Co. KG
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00266526
First Posted
December 16, 2005
Last Updated
March 1, 2013
Sponsor
Allergopharma GmbH & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT00266526
Brief Title
Specific Immunotherapy With Recombinant Birch Pollen Allergen rBet v1-FV
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergopharma GmbH & Co. KG
4. Oversight
5. Study Description
Brief Summary
Specific immunotherapy with recombinant birch pollen allergen rBet v1-FV
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birch Pollen Allergy
Keywords
Allergy, Birch pollen, Recombinant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Recombinant birch pollen
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annemie Narkus, M.D.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergopharma GmbH & Co. KG
City
Reinbek
ZIP/Postal Code
21465
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
26328056
Citation
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.
Results Reference
derived
Links:
URL
http://www.allergopharma.de
Description
Leader in specific allergy research and therapy
Learn more about this trial
Specific Immunotherapy With Recombinant Birch Pollen Allergen rBet v1-FV
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