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Recruiting Phase 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

Phase 4 – monitoring after market approval
Conditions: Allergic Reactions

Sponsor: ARS Pharmaceuticals, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
Neffy
DRUG
Adrenaline
DRUG
Locations 6
United States (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
Technical details
Status
Recruiting
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
4 Years
Healthy volunteers
No
Start date
20.05.2025
Completion date
01.06.2027
Registry ID
NCT06834165
Source
clinicaltrials.gov
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