Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing - Full Text View

Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing (X-PAND)

This study is not yet open for participant recruitment.

Verified by Genentech, December 2008

Sponsored by:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00813748

Purpose

This study will establish a clinical data and serum repository of anaphylaxis cases associated with Xolair administration and control patients who have received Xolair without associated anaphylaxis. This is an observational repository and not an investigational clinical trial. Associated with the repository is an optional skin testing substudy.

Condition	Phase
Allergic Asthma	Phase IV

MedlinePlus related topics: Asthma

Drug Information available for: Omalizumab

U.S. FDA Resources

Study Type:	Observational
Official Title:	Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair(R) Dosing

Further study details as provided by Genentech:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Whole blood

Estimated Enrollment:	150
Study Start Date:	December 2008

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Criteria

Inclusion Criteria for Cases:

Confirmed anaphylaxis based on Sampson criteria subsequent to Xolair

Inclusion Criteria for Controls:

At least 1 patient control among 4 controls who discontinued Xolair for at least 16 weeks but not more than 18 months at enrollment
At least one dose of Xolair in the 18 months before the date of the case event (index date)
No prior anaphylaxis or other hypersensitivity reaction subsequent to Xolair dosing, including any reactions to its components

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813748

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Dennis A. Wong, M.D.

Genentech

More Information

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	Q4458g
Study First Received:	December 22, 2008
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00813748
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

Asthma
Anaphylaxis

Study placed in the following topic categories:

Hypersensitivity
Anaphylaxis
Hypersensitivity, Immediate
Asthma
Omalizumab

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 13, 2009