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

Allergic Asthma Clinical Trial

— X-PAND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00813748
• Other study ID #: Q4458g
• Status: Completed
• Phase: Phase 4
• First received: December 22, 2008
• Last updated: August 14, 2015
• Start date: March 2009
• Est. completion date: January 2014

Study information

• Verified date: August 2015
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Allergic Asthma
• Anaphylaxis

Intervention

Drug:
• Xolair

Locations

Country	Name	City	State
United States	Investigational Site	Blue Bell	Pennsylvania
United States	Investigational Site	Hinsdale	Illinois
United States	Investigational Site	Kansas City	Missouri
United States	Investigational Site	Los Angeles	California
United States	Investigational Site	New York	New York
United States	Investigational Site	San Antonio	Texas
United States	Investigational Site	Valrico	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants		Baseline (Enrollment Visit)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants		Baseline (Enrollment Visit)	No
Primary	Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants		Baseline (Enrollment Visit)	No
Primary	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)	No
Primary	Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants		Baseline (Enrollment Visit)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy		Substudy Day 1	No
Primary	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	No