NCT00813748 - Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing | Crick | Crick

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

N/ACompletedNCT00813748

Genentech, Inc.118 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

118

Conditions

Allergic Asthma

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (7)

Investigational Site

Los Angeles, California, United States

Investigational Site

Valrico, Florida, United States

Investigational Site

Hinsdale, Illinois, United States

Investigational Site

Kansas City, Missouri, United States

Outcomes

Primary Outcomes

Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants

Clinical signs and symptoms of adjudicated anaphylaxis events included: Cutaneous/Subcutaneous/Mucosal, Respiratory (R), Cardiovascular (CV), and Gastrointestinal (GIT) signs and symptoms.

Time frame: Baseline (Enrollment Visit)

Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants

Time frame: Baseline (Enrollment Visit)

Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants

Time from last omalizumab dose to adjudicated anaphylactic symptoms was classified as: less than (\<) 30 minutes, 30-60 minutes, greater than (\>) 60-90 minutes, \>90-120 minutes, \>120 minutes to 360 minutes, and missing. Number of participants in each time category is reported.

Time frame: Baseline (Enrollment Visit)

Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants

Omalizumab doses were classified as: 1 dose, 2 doses, 3 doses, 4-20 doses, 21-40 doses, 41-60 doses, \>60 doses, and missing. Number of participants in each dose category is reported.

Time frame: Baseline (Enrollment Visit)

Treatment Received Following Adjudicated Anaphylactic Event - Case Participants

Treatment received following adjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.

Time frame: Baseline (Enrollment Visit)

Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants

Outcomes of adjudicated anaphylactic event were classified as: death, life-threatening, required in-patient hospitalization or its prolongation, disabling, congenital anomaly/birth defect in offspring of participant, and other (outcome did not meet any of the above criteria, but may jeopardize the participant, and may require medical or surgical intervention to prevent one of the outcomes listed above). Number of participants in each outcome category is reported. Only outcomes with results are reported.

Data from ClinicalTrials.gov

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