- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00309062
Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis
March 8, 2013 updated by: Allergopharma GmbH & Co. KG
A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Immunotherapy With an Aluminium Hydroxide-adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen, Bet v 1
Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic rhinoconjunctivitis
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Reinbek, Germany, 21465
- Allergopharma GmbH & Co. KG
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Positive Skin Prick Test reaction to birch pollen
- Positive RAST result to birch pollen
- Positive Provocation Test result to birch pollen
Exclusion Criteria:
- Serious chronic diseases
- Other perennial allergies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Annemie Narkus, M D
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2003
Primary Completion (Actual)
June 1, 2006
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
March 30, 2006
First Submitted That Met QC Criteria
March 30, 2006
First Posted (Estimate)
March 31, 2006
Study Record Updates
Last Update Posted (Estimate)
March 11, 2013
Last Update Submitted That Met QC Criteria
March 8, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Al0103rB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Birch Pollen Allergy
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Medical University of ViennaAustrian Science Fund (FWF)CompletedBirch Pollen Allergy | Birch Pollen Related Apple AllergyAustria
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MacroArray Diagnostics GmbHCompletedCat Allergy | Grass Pollen Allergy | Birch Pollen Allergy | House Dust Mite Allergy | Bee Venom Allergy | Vespid Venom AllergyAustria
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Desentum OyCompletedBirch Pollen AllergyFinland
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ALK-Abelló A/SCompletedBirch Pollen AllergyFinland, Netherlands
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Desentum OyCompleted
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Assistance Publique - Hôpitaux de ParisIltoo PharmaCompletedAllergic Rhinoconjunctivitis to Birch Pollen | With a Positive Skin Prick Test to Birch PollenFrance
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AnergisCompletedBirch Pollen AllergySweden, France, Lithuania, Denmark, Latvia, Poland, Switzerland
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Allergopharma GmbH & Co. KGCompletedBirch Pollen AllergyGermany
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Regeneron PharmaceuticalsCompletedHealthy Volunteers | Birch Pollen AllergyBelgium
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Rijnstate HospitalWageningen University; NIZO Food Research; Allergologiepraktijk Arnhem/Radboud... and other collaboratorsCompletedHay Fever | Birch Pollen AllergyNetherlands
Clinical Trials on Recombinant birch pollen
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Stallergenes GreerTerminated
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Allergopharma GmbH & Co. KGCompletedBirch Pollen AllergyGermany
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Allergopharma GmbH & Co. KGCompleted
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Fraunhofer-Institute of Toxicology and Experimental...RecruitingAllergic Rhinitis | Seasonal Allergic Rhinitis | Birch Pollen Allergy | Ragweed AllergyGermany
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Queen's UniversityUniversity of British ColumbiaCompleted
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Fraunhofer-Institute of Toxicology and Experimental...Completed
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Helsinki University Central HospitalUniversity of Helsinki; Finnish Institute of Occupational HealthCompletedRhinitis, Allergic, Seasonal
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Royal Sussex County HospitalUnknownOral Allergy SyndromeUnited Kingdom
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AlyatecCompletedAllergic ConjunctivitisFrance
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Stallergenes GreerQuintiles, Inc.; Cenduit LLC; Aptuit Inc.; PHT CorporationCompletedHypersensitivity | Allergic Rhinitis | Allergic Conjunctivitis | Seasonal AllergyCzech Republic, Denmark, Estonia, Finland, France, Germany, Latvia, Lithuania, Poland, Slovakia, Sweden