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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
  Purpose
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.

Condition Intervention Phase
Birch Pollen-Related Rhinoconjunctivitis Rhinitis, Allergic, Seasonal Biological: rBet v 1 Biological: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Stallergenes Greer:

Primary Outcome Measures:
  • Local tolerability [ Time Frame: Assessed every day over 2 weeks ]
  • Global safety [ Time Frame: Assessed every day over 2 weeks ]

Secondary Outcome Measures:
  • Immunological markers (IgE and IgG4) [ Time Frame: Between selection and follow-up visit (up to 18 weeks) ]

Enrollment: 55
Study Start Date: November 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo group
Biological: Placebo
Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
Experimental: 2
rBet v 1 tablets
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

  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:

  • 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
  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): NCT00889460


Locations
Denmark
National University Hospital - Allergy Unit 4222
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Stallergenes Greer
Quintiles, Inc.
Investigators
Principal Investigator: Hans-Jorgen MALLING, Pr. MD National University Hospital - Copenhagen - DENMARK
  More Information

Publications:
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)

Responsible Party: Bruno ROBIN, Stallergenes S.A.
ClinicalTrials.gov Identifier: NCT00889460     History of Changes
Other Study ID Numbers: VO58.07 DK
First Submitted: April 28, 2009
First Posted: April 29, 2009
Last Update Posted: April 29, 2009
Last Verified: April 2009

Keywords provided by Stallergenes Greer:
rBet v 1
Birch pollen allergy
Sublingual Immunotherapy

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases