Safety and Tolerability Study of rBet v1 SLIT Tablets | NCT00889460

Studies
Safety and Tolerability Study of rBet v1 SLIT Tablets

NCT00889460

Sponsor

Stallergenes Greer

Status

Completed

Last Update Posted

Apr 29, 2009Estimated

Enrollment

55Actual

Phase

Phase 1

Conditions

Birch Pollen-Related Rhinoconjunctivitis
Rhinitis, Allergic, Seasonal

Interventions

rBet v 1
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Apr 28, 2009

First Submission Date that Met QC Criteria

Apr 28, 2009

First Posted Date

Apr 29, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2009

Last Update Posted Date

Apr 29, 2009Estimated

Name	Class
Quintiles, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	Placebo group	Biological: Placebo
2	Experimental	rBet v 1 tablets	Biological: rBet v 1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rBet v 1	Biological	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Local tolerability		Assessed every day over 2 weeks
Global safety		Assessed every day over 2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Immunological markers (IgE and IgG4)		Between selection and follow-up visit (up to 18 weeks)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans-Jorgen MALLING, Pr. MD	National University Hospital - Copenhagen - DENMARK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National University Hospital - Allergy Unit 4222		Copenhagen		2100	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	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)

ID	Term
D065631	Rhinitis, Allergic
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases