Performance of CAST (Cellular Antigen Stimulation Test) i... | NCT00794287

Studies
Performance of CAST (Cellular Antigen Stimulation Test) in Patients With Wasp Venom Allergy: Evaluation of Neutralizing IgG Subclasses

NCT00794287

Sponsor

University of Zurich

Status

Withdrawn

Last Update Posted

Jun 4, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Wasp Venom Allergic Patients

Interventions

Taking blood samples

Countries

Switzerland

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

Jun 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2010Estimated

Completion Date

Not provided

First Submitted Date

Nov 19, 2008

First Submission Date that Met QC Criteria

Nov 19, 2008

First Posted Date

Nov 20, 2008Estimated

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

Jun 3, 2015

Last Update Posted Date

Jun 4, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To determine which subclass of IgG in the serum of patients undergoing SIT against wasp venom is able to neutralize the allergen, and therefore to prevent a positive CAST

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Hymenoptera allergic patients before allergen specific immunotherapy	Other: Taking blood samples
2		Hymenoptera allergic patients after allergen specific immunotherapy	Other: Taking blood samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Taking blood samples	Other	No intervention is done. Only blood samples are taken.	1 2

Eligibility Module

Eligibility Criteria

Inclusion criteria:

male and female patient with allergy to wasp venom grade III and IV according to H.L. Müller
18-75 years
planned SIT against wasp venom or finished 5 years SIT against wsp venom (10/10)

Exclusion criteria:

oral corticosteroids
chromogycin
ketotifen
immunosuppressive drugs within the last 2 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Wasp venom allergic patients grade III and IV according to H.L. Müller in the age group of 18-75 years

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
01 Studienregister MasterAdmins	UniversitaetsSpital Zuerich	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Zurich			Switzerland