Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing
| Status: | Completed |
|---|---|
| Conditions: | Allergy, Asthma, Hospital |
| Therapuetic Areas: | Otolaryngology, Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2009 |
| End Date: | January 2014 |
Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair(R) Dosing
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.
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.
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
We found this trial at
7
sites
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