Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing (X-PAND)
8 de junio de 2017 actualizado por: 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.
Descripción general del estudio
Tipo de estudio
De observación
Inscripción (Actual)
118
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90025
- Investigational Site
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Florida
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Valrico, Florida, Estados Unidos, 33596
- Investigational Site
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Illinois
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Hinsdale, Illinois, Estados Unidos, 60521
- Investigational Site
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Missouri
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Kansas City, Missouri, Estados Unidos, 64111
- Investigational Site
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New York
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New York, New York, Estados Unidos, 10022
- Investigational Site
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Pennsylvania
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Blue Bell, Pennsylvania, Estados Unidos, 19422
- Investigational Site
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Texas
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San Antonio, Texas, Estados Unidos, 78229
- Investigational Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
primary care clinic
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants
Periodo de tiempo: Baseline (Enrollment Visit)
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Clinical signs and symptoms of adjudicated anaphylaxis events included: Cutaneous/Subcutaneous/Mucosal, Respiratory (R), Cardiovascular (CV), and Gastrointestinal (GIT) signs and symptoms.
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Baseline (Enrollment Visit)
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Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants
Periodo de tiempo: Baseline (Enrollment Visit)
|
Baseline (Enrollment Visit)
|
|
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Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants
Periodo de tiempo: Baseline (Enrollment Visit)
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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)
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Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants
Periodo de tiempo: Baseline (Enrollment Visit)
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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.
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Baseline (Enrollment Visit)
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Treatment Received Following Adjudicated Anaphylactic Event - Case Participants
Periodo de tiempo: Baseline (Enrollment Visit)
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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.
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Baseline (Enrollment Visit)
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Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants
Periodo de tiempo: Baseline (Enrollment Visit)
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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)
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Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants
Periodo de tiempo: Baseline (Enrollment Visit)
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Baseline (Enrollment Visit)
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Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants
Periodo de tiempo: Baseline (Enrollment Visit)
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Baseline (Enrollment Visit)
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Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants
Periodo de tiempo: Baseline (Enrollment Visit)
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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)
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Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants
Periodo de tiempo: Baseline (Enrollment Visit)
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Baseline (Enrollment Visit)
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Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants
Periodo de tiempo: Baseline (Enrollment Visit)
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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)
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Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Periodo de tiempo: Baseline (Enrollment Visit)
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Number of participants in each medication class is reported.
Participants could have received more than 1 medication class.
NEC: Not Elsewhere Classified.
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Baseline (Enrollment Visit)
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Medications Within Two Weeks Prior to Blood Draw
Periodo de tiempo: Baseline (Enrollment Visit)
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Number of participants in each medication class is reported.
Participants could have received more than 1 medication class.
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Baseline (Enrollment Visit)
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Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study
Periodo de tiempo: Baseline (Enrollment Visit)
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Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported.
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Baseline (Enrollment Visit)
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Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy
Periodo de tiempo: Substudy Day 1
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Substudy Day 1
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Number of Participants With ATA - Skin Testing Substudy
Periodo de tiempo: Substudy Week 10
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Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported.
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Substudy Week 10
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Abdelkader Rahmaoui, M.D., Genentech, Inc.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de marzo de 2009
Finalización primaria (Actual)
1 de enero de 2014
Finalización del estudio (Actual)
1 de enero de 2014
Fechas de registro del estudio
Enviado por primera vez
22 de diciembre de 2008
Primero enviado que cumplió con los criterios de control de calidad
22 de diciembre de 2008
Publicado por primera vez (Estimar)
23 de diciembre de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de julio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
8 de junio de 2017
Última verificación
1 de junio de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Q4458g
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .