Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma

NCT ID: NCT00671268

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

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2013-03-31

Brief Summary

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Efficacy and Safety from a high-dosed subcutaneous recombinant preparation

Detailed Description

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Conditions

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Rhinoconjunctivitis

Keywords

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Grass pollen allergy specific immunotherapy

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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1

strict subcutaneous

Group Type EXPERIMENTAL

AL0704rP

Intervention Type BIOLOGICAL

strict subcutaneous

2

strict subcutaneous

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

strict subcutaneous

Interventions

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AL0704rP

strict subcutaneous

Intervention Type BIOLOGICAL

Placebo

strict subcutaneous

Intervention Type BIOLOGICAL

Other Intervention Names

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"na" "na"

Eligibility Criteria

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Inclusion Criteria

* Allergic rhinoconjunctivitis attributable to grass pollen
* Positive SPT
* Positive EAST
* Positive provocation test

Exclusion Criteria

* serious disease
* 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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Margitta Worm, 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/2007-003208-37/DE

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

Other Identifiers

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2007-003208-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AL0704rP

Identifier Type: -

Identifier Source: org_study_id