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

NCT ID: NCT00554983

Last Updated: 2013-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-05-31

Brief Summary

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

Detailed Description

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Conditions

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Allergy

Keywords

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Recombinant birch pollen allergy IgE-mediated allergic disease attributed to birch pollen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram

1

Group Type EXPERIMENTAL

recombinant birch pollen allergen

Intervention Type BIOLOGICAL

subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram

Interventions

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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

Intervention Type BIOLOGICAL

placebo

subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Serious chronic diseases
* Other perennial allergies
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergopharma GmbH & Co. KG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ludger Klimek, Professor

Role: PRINCIPAL_INVESTIGATOR

Locations

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Allergopharma GmbH & Co. KG

Reinbek, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.allergopharma.de

Leader in specific allergy research and therapy

https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-001029-84/DE

Click here for information about this trial in the European Clinical Trials Register

Other Identifiers

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2007-001029-84

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AL0702rB

Identifier Type: -

Identifier Source: org_study_id