Tolerability of Grazax in Patients With Hayfever in Real Life Settings (GRAAL)

May 28, 2024 updated by: ALK-Abelló A/S

Observational National Clinical Trial of Safety and Tolerance in Patients Suffering of an Allergic Grass Pollen Rhinitis and Treated by Grazax in Real Life Settings

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

628

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44000
        • Centre Hospitalier Universitaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Grazax Tablets 75000 SQT
Timothy Extract
Drug: Grazax
1 tablet/day - pre and co-seasonal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events related to Grazax
Time Frame: From November 2007 to October 2010 (3 years)
All adverse events were reported according to the MedDRA dictionary
From November 2007 to October 2010 (3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Investigators

  • Principal Investigator: François FW Wessel, MD, Centre Hospitalier Universitaire F-44000 Nantes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 12, 2011

First Submitted That Met QC Criteria

September 13, 2011

First Posted (Estimated)

September 14, 2011

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GT-15
  • 2007-003772-20 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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