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Набира участници Фаза 4 NCT06834165

Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy

Фаза 4 – наблюдение след одобрението на пазара
Заболявания: Allergic Reactions

Спонсор: ARS Pharmaceuticals, Inc.

Налично на: БГ
Обобщение
The study is to assess the safety of neffy or IM Adrenalin in patients who are experiencing allergic reactions after an OFC, allergen Immunotherapy (AIT), or other allergy challenge that may require epinephrine intervention.
Кой може да участва
Inclusion Criteria: * Is a patient 4 years old or greater, inclusive, who are scheduled to undergo OFC, AIT, or other relevant allergy challenge. * Has body weight 15 kg or greater at the time of allergy challenge. * Is willing and able to provide written informed consent prior to participating in the study. In the case of minors (\<18 years old), assent can be obtained from his/her legal representative, and as much possible from the patient himself/herself. * Patient experiences an allergic reaction that, in the opinion of the Investigator, requires treatment with epinephrine via neffy or IM Adrenalin. Exclusion Criteria: \- Has any clinically significant medical condition that precludes treatment with epinephrine as assessed by the Investigator.
Интервенции
Neffy
DRUG
Adrenaline
DRUG
Места на провеждане 6
САЩ (6)
University Of Michigan
Ann Arbor , Michigan
Cincinnati Children's Hospital Medical Center
Cincinnati , Ohio
Endeavor Health
Glenview , Illinois
Orso Health, Inc.
La Jolla , California
Weill Cornell Medicine/NewYork Presbyterian Hospital
New York , New York
Miriam Samstein, M.D, Ph.D.
Children's National Hospital
Washington D.C. , District of Columbia
Технически детайли
Статус
Набира участници
Фаза
Фаза 4
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
4 Years
Здрави доброволци
Не
Начална дата
20.05.2025
Крайна дата
01.06.2027
Регистрационен номер
NCT06834165
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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