NCT00889460

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2009

Completed
Last Updated

April 29, 2009

Status Verified

April 1, 2009

Enrollment Period

5 months

First QC Date

April 28, 2009

Last Update Submit

April 28, 2009

Conditions

Birch Pollen-Related RhinoconjunctivitisRhinitis, Allergic, Seasonal

Keywords

rBet v 1Birch pollen allergySublingual Immunotherapy

Outcome Measures

Primary Outcomes (2)

  • Local tolerability

    Assessed every day over 2 weeks

  • Global safety

    Assessed every day over 2 weeks

Secondary Outcomes (1)

  • Immunological markers (IgE and IgG4)

    Between selection and follow-up visit (up to 18 weeks)

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo group

Biological: Placebo

2

EXPERIMENTAL

rBet v 1 tablets

Biological: rBet v 1

Interventions

rBet v 1BIOLOGICAL

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.

Also known as: rBet v 1.0101
2
PlaceboBIOLOGICAL

Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.

1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital - Allergy Unit 4222

Copenhagen, 2100, Denmark

Location

Related Publications (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)

    RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Hans-Jorgen MALLING, Pr. MD

    National University Hospital - Copenhagen - DENMARK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 28, 2009

First Posted

April 29, 2009

Study Start

November 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

April 29, 2009

Record last verified: 2009-04

Locations

DK(1)