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Идёт набор NCT06693531

A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care

— Наблюдательное Eosinophilic Esophagitis (EoE)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: dupilumab.
Кому может быть актуально
Состояния в реестре: Eosinophilic Esophagitis (EoE). Базовые параметры: от 1 год · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

A U.S. Registry of Eosinophilic Esophagitis Patients Treated With DUPIXENT® As Standard of Care

Обзор

This observational research study is to better understand patients with eosinophilic esophagitis (EoE) who have recently been prescribed DUPIXENT® (dupilumab). The purpose of this research study is to look at how DUPIXENT is used in normal care of patients with EoE. Possible benefits to others include a better understanding of EoE and helping to inform research and clinical trial design leading to treatment decisions in this patient population going forward. Patient questionnaires will measure the following: * How EoE makes one feel * EoE signs and/or symptoms, eg, how difficult it is to swallow * How EoE affects quality-of-life * How EoE impacts aspects of daily life * How EoE symptoms have changed throughout the study

Вмешательства

  • Препарат dupilumab
    No investigational agents will be provided. Dupilumab will be prescribed as per usual clinical practice and will not be provided by the sponsor.

Первичные конечные точки

  • Demographic characteristic of participants who receive dupilumab for EoE: Age [Срок оценки: Baseline and up to 3 years after treatment initiation]
  • Demographic characteristic of participants who receive dupilumab for EoE: Race [Срок оценки: Baseline and up to 3 years after treatment initiation]
  • Demographic characteristic of participants who receive dupilumab for EoE: Weight [Срок оценки: Baseline and up to 3 years after treatment initiation]
  • Demographic characteristic of participants who receive dupilumab for EoE: Height [Срок оценки: Baseline and up to 3 years after treatment initiation]
  • Disease characteristics of participants who receive dupilumab for EoE: Esophagogastroduodenoscopy (EGD) [Срок оценки: Baseline and up to 3 years after treatment initiation]
  • Disease characteristics of participants who receive dupilumab for EoE: Dilation/impaction history [Срок оценки: Baseline and up to 3 years after treatment initiation]
  • Disease characteristics of participants who receive dupilumab for EoE: Dietary interventions [Срок оценки: Baseline and up to 3 years after treatment initiation]
  • Disease characteristics of participants who receive dupilumab for EoE: Medical history [Срок оценки: Baseline and up to 3 years after treatment initiation]
  • EoE medication history of participant [Срок оценки: Previous 1 year and up to 3 years after treatment initiation]
  • Non-EoE medication history of participant [Срок оценки: Previous 3 months and up to 3 years after treatment initiation]

Критерии участия

Критерии включения

  • Initiating treatment with DUPIXENT® for EoE according to the USPI
  • Participants aged ≥12 years and caregivers or legal guardians of participants aged <12 years must be able to understand and complete registry-related questionnaires

Критерии исключения

  • Patients who have a contraindication to DUPIXENT® according to the USPI
  • Treatment with DUPIXENT® within the 6 months prior to the screening assessment
  • Participation in an ongoing interventional study on or within 6 months of the baseline assessment. Once enrolled in registry, participation is allowed in other ongoing studies (at the discretion of the registry investigator)

NOTE: Other protocol defined inclusion/exclusion criteria apply

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 55 центров
  • Phoenix Childrens Hospital — Phoenix
  • Arizona Digestive Health/GI Alliance — Sun City
  • Arkansas Childrens Hospital — Little Rock
  • Scripps Clinic — La Jolla
  • University of California Los Angeles (UCLA) — Los Angeles
  • University of Southern California Keck School of Medicine — Los Angeles
  • University of California, San Francisco — Oakland
  • Stanford University — Palo Alto
  • … и ещё 47 центров

Публикации

  • Dellon ES, Chehade M, McGowan EC, Jensen ET, Leung J, Eren D, Angello JT, Radwan A, Durrani SR, deMarchi S. Baseline characteristics, treatment patterns, and long-term outcomes in patients with eosinophilic esophagitis initiating dupilumab in routine clinical practice: study protocol of a phase IV, prospective, observational, multicenter registry (EDESIA). Ther Adv Gastroenterol. 2026 Apr 28;19:17 PMID 42100495

Идентификаторы

NCT: NCT06693531 · R668-EE-2328

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗