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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00813748
First received: December 22, 2008
Last updated: August 14, 2015
Last verified: August 2015
  Purpose
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.

Condition Intervention Phase
Allergic Asthma
Drug: Xolair
Phase 4

Study Type: Observational
Official Title: Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair(R) Dosing

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants [ Time Frame: Baseline (Enrollment Visit) ] [ Designated as safety issue: No ]
    Clinical signs and symptoms of adjudicated anaphylaxis events included: Cutaneous/Subcutaneous/Mucosal, Respiratory (R), Cardiovascular (CV), and Gastrointestinal (GIT) signs and symptoms.

  • Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants [ Time Frame: Baseline (Enrollment Visit) ] [ Designated as safety issue: No ]
  • Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants [ Time Frame: Baseline (Enrollment Visit) ] [ Designated as safety issue: No ]
    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.

  • Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants [ Time Frame: Baseline (Enrollment Visit) ] [ Designated as safety issue: No ]
    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.

  • Treatment Received Following Adjudicated Anaphylactic Event - Case Participants [ Time Frame: Baseline (Enrollment Visit) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Enrollment Visit) ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants [ Time Frame: Baseline (Enrollment Visit) ] [ Designated as safety issue: No ]
  • Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants [ Time Frame: Baseline (Enrollment Visit) ] [ Designated as safety issue: No ]
  • Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants [ Time Frame: Baseline (Enrollment Visit) ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants [ Time Frame: Baseline (Enrollment Visit) ] [ Designated as safety issue: No ]
  • Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants [ Time Frame: Baseline (Enrollment Visit) ] [ Designated as safety issue: No ]
    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.

  • Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants [ Time Frame: Baseline (Enrollment Visit) ] [ Designated as safety issue: No ]
    Number of participants in each medication class is reported. Participants could have received more than 1 medication class. NEC: Not Elsewhere Classified.

  • Medications Within Two Weeks Prior to Blood Draw [ Time Frame: Baseline (Enrollment Visit) ] [ Designated as safety issue: No ]
    Number of participants in each medication class is reported. Participants could have received more than 1 medication class.

  • Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study [ Time Frame: Baseline (Enrollment Visit) ] [ Designated as safety issue: No ]
    Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported.

  • Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy [ Time Frame: Substudy Day 1 ] [ Designated as safety issue: No ]
  • Number of Participants With ATA - Skin Testing Substudy [ Time Frame: Substudy Week 10 ] [ Designated as safety issue: No ]
    Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported.


Biospecimen Retention:   Samples With DNA
Whole blood

Enrollment: 118
Study Start Date: March 2009
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813748

Locations
United States, California
Investigational Site
Los Angeles, California, United States, 90025
United States, Florida
Investigational Site
Valrico, Florida, United States, 33596
United States, Illinois
Investigational Site
Hinsdale, Illinois, United States, 60521
United States, Missouri
Investigational Site
Kansas City, Missouri, United States, 64111
United States, New York
Investigational Site
New York, New York, United States, 10022
United States, Pennsylvania
Investigational Site
Blue Bell, Pennsylvania, United States, 19422
United States, Texas
Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Abdelkader Rahmaoui, M.D. Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00813748     History of Changes
Other Study ID Numbers: Q4458g 
Study First Received: December 22, 2008
Results First Received: August 14, 2015
Last Updated: August 14, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
Asthma
Anaphylaxis

Additional relevant MeSH terms:
Anaphylaxis
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 23, 2016