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

Completed

• Conditions: Allergic Asthma

• Registration Number: NCT00813748
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-22
• Study First Submitted QC: 2008-12-22
• Study First Posted: 2008-12-23
• Study Start: 2009-03
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Results First Submitted: 2015-08-14
• Results First Submitted QC: 2015-08-14
• Results First Posted: 2015-09-15
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-08
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants	Baseline (Enrollment Visit)
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants	Baseline (Enrollment Visit)	Number of participants in each medication class is reported. Participants could have received more than 1 medication class. NEC: Not Elsewhere Classified.
Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy	Substudy Day 1
Number of Participants With ATA - Skin Testing Substudy	Substudy Week 10	Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported.
Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants	Baseline (Enrollment Visit)	Clinical signs and symptoms of adjudicated anaphylaxis events included: Cutaneous/Subcutaneous/Mucosal, Respiratory (R), Cardiovascular (CV), and Gastrointestinal (GIT) signs and symptoms.
Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants	Baseline (Enrollment Visit)	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.
Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants	Baseline (Enrollment Visit)
Medications Within Two Weeks Prior to Blood Draw	Baseline (Enrollment Visit)	Number of participants in each medication class is reported. Participants could have received more than 1 medication class.
Treatment Received Following Adjudicated Anaphylactic Event - Case Participants	Baseline (Enrollment Visit)	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.
Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants	Baseline (Enrollment Visit)	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.
Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants	Baseline (Enrollment Visit)
Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants	Baseline (Enrollment Visit)	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.
Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants	Baseline (Enrollment Visit)
Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants	Baseline (Enrollment Visit)	Treatment received following prior unadjudicated anaphylactic events 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.
Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants	Baseline (Enrollment Visit)	Treatment received following subsequent unadjudicated 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.
Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study	Baseline (Enrollment Visit)	Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported.

Trial Locations

Locations (1)

Investigational Site; 🇺🇸 San Antonio, Texas, United States