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Safety and Tolerability Study of rBet v1 SLIT Tablets

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00889460
First Posted: April 29, 2009
Last Update Posted: April 29, 2009
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.
Collaborator:
Quintiles, Inc.
Information provided by:
Stallergenes Greer
April 28, 2009
April 29, 2009
April 29, 2009
November 2007
April 2008   (Final data collection date for primary outcome measure)
  • Local tolerability [ Time Frame: Assessed every day over 2 weeks ]
  • Global safety [ Time Frame: Assessed every day over 2 weeks ]
Same as current
No Changes Posted
Immunological markers (IgE and IgG4) [ Time Frame: Between selection and follow-up visit (up to 18 weeks) ]
Same as current
Not Provided
Not Provided
 
Safety and Tolerability Study of rBet v1 SLIT Tablets
Phase I Study to re-Investigate the Safety, Tolerability and Pharmacodynamic Effects of SLIT(Tablets) With Recombinant Bet v1 Given in Single Rising Doses and in Multi Dose Regimens to Subjects Sensitised to Birch Pollen
The purpose of this study is to determine the safety and tolerability of several doses of r Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Birch Pollen-Related Rhinoconjunctivitis
  • Rhinitis, Allergic, Seasonal
  • Biological: rBet v 1
    Two tablets (1 placebo + 1 rBet v 1 or 2 rBet v 1) were administered every day over 2 weeks with a 2-day break for the week-end. Administered doses ranged from 12.5 to 100 µg rBet v 1.
    Other Name: rBet v 1.0101
  • Biological: Placebo
    Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
  • Placebo Comparator: 1
    Placebo group
    Intervention: Biological: Placebo
  • Experimental: 2
    rBet v 1 tablets
    Intervention: Biological: rBet v 1
L. Winther, L.K. Poulsen, B. Robin, M. Mélac, H. Malling Safety and Tolerability of Recombinant Bet v 1 (rBet v 1) Tablets in Sublingual Immunotherapy (SLIT) The Journal of Allergy and Clinical Immunology February 2009 (Vol. 123, Issue 2, Page S215)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
April 2008
April 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • written consent
  • Male or female subject from 18 to 60 years old and in general good health
  • For woman of child bearing potential:
  • Symptoms of birch pollen induced allergic rhinitis for at least the last 2 years.
  • Sensitisation to birch pollen as demonstrated with a positive SPT to birch pollen and specific IgE level (birch pollen and r Bet v1) >0.70 kU/L at screening.
  • FEV1 at least of 80% of predicted values at screening.
  • Subject accepting to comply fully with the protocol.

Exclusion Criteria:

  • Past or current disease which as judged by the Investigator, may affect the outcome of this study.
  • History of life-threatening asthma,
  • Asthma requiring daily treatment (whatever the pharmaceutical class).
  • Pregnant or lactating woman.
  • Subject being treated with inhaled steroids within 4 weeks prior to screening visit or within 12 weeks prior to screening visit.
  • Subject who previously received desensitisation treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder) or who plan to start desensitisation treatment during this study.
  • Symptoms during the treatment phase due to a sensitivity to a second allergen.
  • Subjects treated with ongoing immunotherapy with another allergen
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00889460
VO58.07 DK
No
Not Provided
Not Provided
Bruno ROBIN, Stallergenes S.A.
Stallergenes Greer
Quintiles, Inc.
Principal Investigator: Hans-Jorgen MALLING, Pr. MD National University Hospital - Copenhagen - DENMARK
Stallergenes Greer
April 2009

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