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

  • Germany
      • Reinbek, Germany, 21465
        • Allergopharma GmbH & Co. KG

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

Allergopharma GmbH & Co. KG

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.

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