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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00554983
First Posted: November 7, 2007
Last Update Posted: November 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
  Purpose
Efficacy and Safety from a recombinant folding variant of Bet v 1

Condition Intervention Phase
Allergy Biological: recombinant birch pollen allergen Biological: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Allergopharma GmbH & Co. KG:

Primary Outcome Measures:
  • Symptom-Medication-Score [ Time Frame: during pollen season ]

Enrollment: 255
Study Start Date: September 2007
Study Completion Date: May 2012
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2 Biological: placebo
subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram
Experimental: 1 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Serious chronic diseases
  • Other perennial allergies
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554983


Locations
Germany
Allergopharma GmbH & Co. KG
Reinbek, Germany, 21465
Sponsors and Collaborators
Allergopharma GmbH & Co. KG
Investigators
Principal Investigator: Ludger Klimek, Professor
  More Information

Additional Information:
Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00554983     History of Changes
Other Study ID Numbers: AL0702rB
2007-001029-84 ( EudraCT Number )
First Submitted: November 6, 2007
First Posted: November 7, 2007
Last Update Posted: November 8, 2013
Last Verified: November 2013

Keywords provided by Allergopharma GmbH & Co. KG:
Recombinant birch pollen allergy
IgE-mediated allergic disease attributed to birch pollen