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Completed

NCT Number: NCT00813748

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

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.

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Key information

Conditions

Allergic Asthma Anaphylaxis Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xolair

Drug

Primary outcomes

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

    Time frame: 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.

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

    Time frame: Baseline (Enrollment Visit)

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

    Time frame: 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.

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

    Time frame: 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.

  5. Treatment Received Following Adjudicated Anaphylactic Event - Case Participants

    Time frame: 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.

  6. Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants

    Time frame: 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.

  7. Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants

    Time frame: Baseline (Enrollment Visit)

  8. Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants

    Time frame: Baseline (Enrollment Visit)

  9. Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants

    Time frame: 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.

  10. Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants

    Time frame: Baseline (Enrollment Visit)

  11. Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants

    Time frame: 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.

  12. Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants

    Time frame: 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.

  13. Medications Within Two Weeks Prior to Blood Draw

    Time frame: Baseline (Enrollment Visit)

    Number of participants in each medication class is reported. Participants could have received more than 1 medication class.

  14. Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study

    Time frame: Baseline (Enrollment Visit)

    Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported.

  15. Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy

    Time frame: Substudy Day 1

  16. Number of Participants With ATA - Skin Testing Substudy

    Time frame: Substudy Week 10

    Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported.

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Acronym: X-PAND

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Dec 23, 2008
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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