Clinical trial NCT00813748: Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing
Official title: Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair(R) Dosing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Asthma
Keywords: Asthma
Anaphylaxis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-23
Enrollment: 118
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

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


Eligibility 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

Primary outcomes:
measure: Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants
timeFrame: Baseline (Enrollment Visit)
measure: Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants
timeFrame: Baseline (Enrollment Visit)
measure: Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants
timeFrame: Baseline (Enrollment Visit)
measure: Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants
timeFrame: Baseline (Enrollment Visit)
measure: Treatment Received Following Adjudicated Anaphylactic Event - Case Participants
timeFrame: Baseline (Enrollment Visit)
measure: Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants
timeFrame: Baseline (Enrollment Visit)
measure: Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants
timeFrame: Baseline (Enrollment Visit)
measure: Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants
timeFrame: Baseline (Enrollment Visit)
measure: Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants
timeFrame: Baseline (Enrollment Visit)
measure: Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants
timeFrame: Baseline (Enrollment Visit)
measure: Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants
timeFrame: Baseline (Enrollment Visit)
measure: Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
timeFrame: Baseline (Enrollment Visit)
measure: Medications Within Two Weeks Prior to Blood Draw
timeFrame: Baseline (Enrollment Visit)
measure: Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study
timeFrame: Baseline (Enrollment Visit)
measure: Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy
timeFrame: Substudy Day 1
measure: Number of Participants With ATA - Skin Testing Substudy
timeFrame: Substudy Week 10
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Investigational Site
state: California
city: Valrico
country: United States
facility: Investigational Site
state: Florida
city: Hinsdale
country: United States
facility: Investigational Site
state: Illinois
city: Kansas City
country: United States
facility: Investigational Site
state: Missouri
city: New York
country: United States
facility: Investigational Site
state: New York
city: Blue Bell
country: United States
facility: Investigational Site
state: Pennsylvania
city: San Antonio
country: United States
facility: Investigational Site
state: Texas
Study officials:
affiliation: Genentech, Inc.
name: Abdelkader Rahmaoui, M.D.
role: STUDY_DIRECTOR
References: