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NCT00554983 Clinical Trial

Efficacy and Safety From a Recombinant Folding Variant of Bet v 1

Allergy Clinical Trial

Official title:
A Multicentre Randomised Placebo-controlled Double-blind Pivotal Clinical Trial for the Evaluation of Safety and Efficacy of Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen, rBet v 1-FV

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00554983
Other study ID # AL0702rB
Secondary ID 2007-001029-84
Status Completed
Phase Phase 3
First received November 6, 2007
Last updated November 7, 2013
Start date September 2007
Est. completion date May 2012

Study information
Verified date November 2013
Source Allergopharma GmbH & Co. KG
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

Efficacy and Safety from a recombinant folding variant of Bet v 1

Recruitment information / eligibility
Status Completed
Enrollment 255
Est. completion date May 2012
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Allergic rhinoconjunctivitis attributable to birch pollen

- Positive SPT

- Positive EAST

- Positive specific provocation test

Exclusion Criteria:

- Serious chronic diseases

- Other perennial allergies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• recombinant birch pollen allergen
subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram
• placebo
subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram

Locations
Country Name City State
Germany Allergopharma GmbH & Co. KG Reinbek

Sponsors (1)
Lead Sponsor Collaborator
Allergopharma GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptom-Medication-Score during pollen season No
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