ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00554983
Recruitment Status : Completed
First Posted : November 7, 2007
Last Update Posted : November 8, 2013
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG

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

Condition or disease Intervention/treatment Phase
Allergy Biological: recombinant birch pollen allergen Biological: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
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
Study Start Date : September 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Bee pollen
U.S. FDA Resources

Arm Intervention/treatment
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



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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

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 Posted: November 7, 2007    Key Record Dates
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