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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00554983
First received: November 6, 2007
Last updated: November 7, 2013
Last verified: November 2013

November 6, 2007
November 7, 2013
September 2007
June 2010   (final data collection date for primary outcome measure)
Symptom-Medication-Score [ Time Frame: during pollen season ] [ Designated as safety issue: No ]
Symptom-Medication-Score [ Time Frame: during pollen season ]
Complete list of historical versions of study NCT00554983 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Allergy
  • 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
  • Placebo Comparator: 2
    Intervention: Biological: placebo
  • Experimental: 1
    Intervention: Biological: recombinant birch pollen allergen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
May 2012
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Serious chronic diseases
  • Other perennial allergies
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00554983
AL0702rB, 2007-001029-84
No
Allergopharma GmbH & Co. KG
Allergopharma GmbH & Co. KG
Not Provided
Principal Investigator: Ludger Klimek, Professor
Allergopharma GmbH & Co. KG
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP