Status:
COMPLETED
Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing
Lead Sponsor:
Genentech, Inc.
Conditions:
Allergic Asthma
Eligibility:
All Genders
Brief Summary
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. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00813748
Start Date
March 1 2009
End Date
January 1 2014
Last Update
July 11 2017
Active Locations (7)
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1
Investigational Site
Los Angeles, California, United States, 90025
2
Investigational Site
Valrico, Florida, United States, 33596
3
Investigational Site
Hinsdale, Illinois, United States, 60521
4
Investigational Site
Kansas City, Missouri, United States, 64111