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

8 juni 2017 bijgewerkt door: Genentech, Inc.

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

Studie Overzicht

Toestand

Voltooid

Conditie

Allergisch astma

Interventie / Behandeling

Geneesmiddel: Xolair

Studietype

Observationeel

Inschrijving (Werkelijk)

118

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- California
  - Los Angeles, California, Verenigde Staten, 90025
    - Investigational Site
- Florida
  - Valrico, Florida, Verenigde Staten, 33596
    - Investigational Site
- Illinois
  - Hinsdale, Illinois, Verenigde Staten, 60521
    - Investigational Site
- Missouri
  - Kansas City, Missouri, Verenigde Staten, 64111
    - Investigational Site
- New York
  - New York, New York, Verenigde Staten, 10022
    - Investigational Site
- Pennsylvania
  - Blue Bell, Pennsylvania, Verenigde Staten, 19422
    - Investigational Site
- Texas
  - San Antonio, Texas, Verenigde Staten, 78229
    - Investigational Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Kind
Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

primary care clinic

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants Tijdsspanne: 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.	Baseline (Enrollment Visit)
Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants Tijdsspanne: Baseline (Enrollment Visit)		Baseline (Enrollment Visit)
Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants Tijdsspanne: 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.	Baseline (Enrollment Visit)
Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants Tijdsspanne: 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.	Baseline (Enrollment Visit)
Treatment Received Following Adjudicated Anaphylactic Event - Case Participants Tijdsspanne: 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.	Baseline (Enrollment Visit)
Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants Tijdsspanne: 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.	Baseline (Enrollment Visit)
Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants Tijdsspanne: Baseline (Enrollment Visit)		Baseline (Enrollment Visit)
Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants Tijdsspanne: Baseline (Enrollment Visit)		Baseline (Enrollment Visit)
Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants Tijdsspanne: 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.	Baseline (Enrollment Visit)
Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants Tijdsspanne: Baseline (Enrollment Visit)		Baseline (Enrollment Visit)
Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants Tijdsspanne: 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.	Baseline (Enrollment Visit)
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants Tijdsspanne: 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.	Baseline (Enrollment Visit)
Medications Within Two Weeks Prior to Blood Draw Tijdsspanne: Baseline (Enrollment Visit)	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 Tijdsspanne: Baseline (Enrollment Visit)	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 Tijdsspanne: Substudy Day 1		Substudy Day 1
Number of Participants With ATA - Skin Testing Substudy Tijdsspanne: Substudy Week 10	Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported.	Substudy Week 10

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Genentech, Inc.

Onderzoekers

Studie directeur: Abdelkader Rahmaoui, M.D., Genentech, Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 maart 2009

Primaire voltooiing (Werkelijk)

1 januari 2014

Studie voltooiing (Werkelijk)

1 januari 2014

Studieregistratiedata

Eerst ingediend

22 december 2008

Eerst ingediend dat voldeed aan de QC-criteria