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OpenTrials
Completed

NCT Number: NCT00554983

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

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

Completed

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Key information

Conditions

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

  • Allergic rhinoconjunctivitis attributable to birch pollen
  • Positive SPT
  • Positive EAST
  • Positive specific provocation test

Exclusion criteria

  • Serious chronic diseases
  • Other perennial allergies

Treatment and study plan

recombinant birch pollen allergen

Biological

subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram

Placebo

Biological

subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram

Primary outcomes

  1. Symptom-Medication-Score

    Time frame: during pollen season

Sponsors and collaborators

Lead sponsor

Allergopharma GmbH & Co. KG

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2012
First posted
Nov 7, 2007
Registry last updated
Nov 8, 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.

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