NCT01433510

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
628

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2011

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

2.9 years

First QC Date

September 12, 2011

Last Update Submit

May 28, 2024

Conditions

Allergic Rhinoconjunctivitis

Keywords

AllergicRhinoconjunctivitisImmunotherapy

Outcome Measures

Primary Outcomes (1)

  • Adverse Events related to Grazax

    All adverse events were reported according to the MedDRA dictionary

    From November 2007 to October 2010 (3 years)

Study Arms (1)

Grazax Tablets 75000 SQT

EXPERIMENTAL

Timothy Extract

Drug: Grazax

Interventions

GrazaxDRUG

1 tablet/day - pre and co-seasonal

Grazax Tablets 75000 SQT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Severe, unstable or uncontrolled asthma (FEV1\<70% of predicted value)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire

Nantes, 44000, France

Location

Related Publications (1)

  • 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.

    PMID: 22594491DERIVED

MeSH Terms

Interventions

Grazax

Study Officials

  • François FW Wessel, MD

    Centre Hospitalier Universitaire F-44000 Nantes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2011

First Posted

September 14, 2011

Study Start

November 1, 2007

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

May 29, 2024

Record last verified: 2024-05

Locations

FR(1)