Changes in the Immune Response and Skin Reactivity of Gra... | NCT00413556

Studies
Changes in the Immune Response and Skin Reactivity of Grass Pollen Allergic Patients Treated With ALK Grass Tablets

NCT00413556

Sponsor

ALK-Abelló A/S

Status

Completed

Last Update Posted

Mar 6, 2008Estimated

Enrollment

76Actual

Phase

Phase 3

Conditions

Allergy

Interventions

ALK Grass tablet

Countries

Spain

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

Status Module

Record Verification Date

Mar 2008

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

Jan 2007

Primary Completion Date

Aug 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Dec 18, 2006

First Submission Date that Met QC Criteria

Dec 18, 2006

First Posted Date

Dec 19, 2006Estimated

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

Mar 4, 2008

Last Update Posted Date

Mar 6, 2008Estimated

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

We plan to determine changes in the immune system during the allergic response to grass pollen allergens. We have chosen a particular element of the immune response, the immunoglobulin G4 (IgG4) as an indicator.

We hypothesize that treatment with Grazax will increase serum levels of Phleum pratense specific IgG4 and IgE, as well as reduce the cutaneous sensitivity of the early (IgE mediated) and late (cell mediated) allergic response.

Detailed Description

Not provided

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Label	Type	Description	Intervention Names
1	Active Comparator		Biological: ALK Grass tablet
2	Placebo Comparator		Biological: ALK Grass tablet

Name	Type	Description	Arm Group Labels	Other Names
ALK Grass tablet	Biological		1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in serum leves of IgG4		6 months

Secondary Outcomes

Measure	Description	Time Frame
Changes in IgE level		6 months
Changes in cutaneous response		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A history of grass pollen allergy
Positive skin prick test to grass
Positive specific IgE to grass

Exclusion Criteria:

Treatment with anti-IgE

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pilar Rico, MD	Medical Director, ALK-Abello, S.A.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinico San Carlos		Madrid	Madrid	28040	Spain

Condition Browse Module

MeSH Terms

ID	Term
D006967	Hypersensitivity
D012220	Rhinitis

Ancestor Terms

ID	Term
D007154	Immune System Diseases
D012141	Respiratory Tract Infections
D007239	Infections
D009668	Nose Diseases

Browse Leaves

Not provided

Browse Branches

Not provided