NCT00813748|CompletedResults
Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing
X-PAND
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X-PAND
Sponsor study identifier
observational
118
1 country
7
Study Start
March 2009
Actual (reported)Primary Completion
January 2014
Actual (reported)Study Completion
January 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 22, 2008
Actual (reported)December 23, 2008
Actual (reported)March 2009
Actual (reported)January 2014
Actual (reported)January 2014
Actual (reported)September 15, 2015
Actual (reported)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.
Baseline (Enrollment Visit)
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
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.
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.
Baseline (Enrollment Visit)
primary care clinic
Investigational Site
Los Angeles, California, 90025, United States
Investigational Site
Valrico, Florida, 33596, United States
Investigational Site
Hinsdale, Illinois, 60521, United States
Investigational Site
Kansas City, Missouri, 64111, United States
Investigational Site
New York, New York, 10022, United States
Investigational Site
Blue Bell, Pennsylvania, 19422, United States
Investigational Site
San Antonio, Texas, 78229, United States
Whole blood
Endpoint prioritization was not specified in study protocol; hence, all endpoints are reported as primary.
Abdelkader Rahmaoui, M.D.
Genentech, Inc.
118 participants (actual enrollment reported by the registry).
First Submitted
December 22, 2008
First Posted
December 23, 2008
Study Start
March 2009
Actual (reported)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.
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.
Baseline (Enrollment Visit)
Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants
Baseline (Enrollment Visit)
Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants
Baseline (Enrollment Visit)
Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants
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.
Baseline (Enrollment Visit)
Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants
Baseline (Enrollment Visit)
Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants
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.
Baseline (Enrollment Visit)
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Number of participants in each medication class is reported. Participants could have received more than 1 medication class. NEC: Not Elsewhere Classified.
Baseline (Enrollment Visit)
Medications Within Two Weeks Prior to Blood Draw
Number of participants in each medication class is reported. Participants could have received more than 1 medication class.
Baseline (Enrollment Visit)
Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study
Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported.
Baseline (Enrollment Visit)
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
Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported.
Substudy Week 10
Contact the study team to confirm eligibility.
Primary Completion
January 2014
Actual (reported)Study Completion
January 2014
Actual (reported)Last Updated
July 11, 2017
Results First Posted
September 15, 2015
Record last verified: 2017-06
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Source: ClinicalTrials.gov.
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