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

NCT00813748 | Completed Results

• 1 other identifier: Q4458g
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 7

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.

Conditions

Allergic Asthma

Keywords

Asthma; Anaphylaxis

Outcome Measures

Primary Outcomes (16)

• 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)

• 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

Interventions

Xolair DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• Confirmed anaphylaxis based on Sampson criteria subsequent to Xolair
• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (7)

Investigational Site

Los Angeles, California, 90025, United States

Location

Investigational Site

Valrico, Florida, 33596, United States

Location

Investigational Site

Hinsdale, Illinois, 60521, United States

Location

Investigational Site

Kansas City, Missouri, 64111, United States

Location

Investigational Site

New York, New York, 10022, United States

Location

Investigational Site

Blue Bell, Pennsylvania, 19422, United States

Location

Investigational Site

San Antonio, Texas, 78229, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Asthma; Anaphylaxis

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Limitations and Caveats

Endpoint prioritization was not specified in study protocol; hence, all endpoints are reported as primary.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Abdelkader Rahmaoui, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: December 23, 2008
• Study Start: March 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: July 11, 2017
• Results First Posted: September 15, 2015

Record last verified: 2017-06

Locations

US (7)