Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis

Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic rhinoconjunctivitis

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Key information

Conditions

Birch Pollen Allergy Hypersensitivity Immune System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Allergopharma GmbH & Co. KG

Reinbek, 21465, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recombinant birch pollen

Biological

Sponsors and collaborators

Lead sponsor

Allergopharma GmbH & Co. KG

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2006
Study completion: 2009
First posted: Mar 31, 2006
Registry last updated: Mar 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed