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

8 juin 2017 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Asthme allergique

Intervention / Traitement

Médicament: Xolair

Type d'étude

Observationnel

Inscription (Réel)

118

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Enfant
Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

primary care clinic

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants Délai: 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 Délai: Baseline (Enrollment Visit)		Baseline (Enrollment Visit)
Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: Baseline (Enrollment Visit)		Baseline (Enrollment Visit)
Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants Délai: Baseline (Enrollment Visit)		Baseline (Enrollment Visit)
Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants Délai: 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 Délai: Baseline (Enrollment Visit)		Baseline (Enrollment Visit)
Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: Substudy Day 1		Substudy Day 1
Number of Participants With ATA - Skin Testing Substudy Délai: Substudy Week 10	Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported.	Substudy Week 10

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Genentech, Inc.

Les enquêteurs

Directeur d'études: Abdelkader Rahmaoui, M.D., Genentech, Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mars 2009

Achèvement primaire (Réel)

1 janvier 2014

Achèvement de l'étude (Réel)

1 janvier 2014

Dates d'inscription aux études

Première soumission

22 décembre 2008

Première soumission répondant aux critères de contrôle qualité