Tolerability of Grazax in Patients With Hayfever in Real... | NCT01433510

Studies
Tolerability of Grazax in Patients With Hayfever in Real Life Settings

NCT01433510

Sponsor

ALK-Abelló A/S

Status

Completed

Last Update Posted

May 29, 2024Actual

Enrollment

628Actual

Phase

Phase 4

Conditions

Allergic Rhinoconjunctivitis

Interventions

Grazax

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007-003772-20	EudraCT Number

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Oct 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Sep 12, 2011

First Submission Date that Met QC Criteria

Sep 13, 2011

First Posted Date

Sep 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2024

Last Update Posted Date

May 29, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

628Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Grazax Tablets 75000 SQT	Experimental	Timothy Extract	Drug: Grazax

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Grazax	Drug	1 tablet/day - pre and co-seasonal	Grazax Tablets 75000 SQT

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
François FW Wessel, MD	Centre Hospitalier Universitaire F-44000 Nantes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire		Nantes		44000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22594491	Derived	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.