NCT00554983

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Allergopharma GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Allergy

Interventions

Type	Name	Description
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
BIOLOGICAL	placebo	subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram

Timeline

• Start date: 2007-09-01
• Primary completion: 2010-06-01
• Completion: 2012-05-01
• First posted: 2007-11-07
• Last updated: 2013-11-08

Locations

1 site across 1 country: Germany