Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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. This is an observational repository and not an investigational clinical trial. Associated with the repository is an optional skin testing substudy.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Omalizumab

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