Tolerability of Grazax in Patients With Hayfever in Real Life Settings

NCT ID: NCT01433510

Last Updated: 2024-05-29

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

PHASE4

Total Enrollment

628 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-12-31

Brief Summary

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The purpose of this study is to assess the safety profile of specific immunotherapy with Grazax for three consecutive grass pollen seasons.

Detailed Description

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To assess the safety profile with Grazax according to the presence or not of polysensitization and/or asthma at enrollment

Conditions

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Allergic Rhinoconjunctivitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Grazax Tablets 75000 SQT

Timothy Extract

Group Type EXPERIMENTAL

Grazax

Intervention Type DRUG

1 tablet/day - pre and co-seasonal

Interventions

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Grazax

1 tablet/day - pre and co-seasonal

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* History of grass pollen allergy
* Positive skin prick-test and/or positive specific IgE to grass

Exclusion Criteria

* Severe, unstable or uncontrolled asthma (FEV1\<70% of predicted value)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ALK-Abelló A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François FW Wessel, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire F-44000 Nantes

Locations

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Centre Hospitalier Universitaire

Nantes, , France

Site Status

Countries

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France

References

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Wessel F, Chartier A, Meunier JP, Magnan A. Safety and tolerability of an SQ-standardized GRAss ALlergy immunotherapy tablet (GRAZAX(R)) in a real-life setting for three consecutive seasons - the GRAAL trial. Clin Drug Investig. 2012 Jul 1;32(7):451-63. doi: 10.2165/11634270-000000000-00000.

Reference Type DERIVED
PMID: 22594491 (View on PubMed)

Other Identifiers

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2007-003772-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GT-15

Identifier Type: -

Identifier Source: org_study_id

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