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

Genentech

Status: Completed

Conditions: Allergic Asthma

Treatments: Drug: Xolair

Study type: Observational

Funder types: Industry

Identifiers

NCT00813748

Q4458g

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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