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NCT02203799 · ClinicalTrials.gov registry record · Phase 1
Peanut Oral Immunotherapy in Children With Peanut Allergy (Peanut Flour)
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT02203799 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 15 participants.
The verdict
NCT02203799, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
Many children who are allergic to peanuts do not outgrow their allergy and have very severe allergic reactions called anaphylaxis. Symptoms of anaphylaxis include difficulty breathing, decreased blood pressure, hives, and lip or throat swelling after exposure to an allergen. A severe allergic reaction can lead to death if not treated appropriately. The purpose of this study is to find out if there is a way to treat children with peanut allergy to help lower the risk of severe allergic reactions and also cause them to lose their allergy to peanuts. The approach that will used for this study is a process called "desensitization". Oral immunotherapy involves eating gradually increasing amounts of a food over several months. This is a research study because at this time peanut oral immunotherapy (OIT) is investigational. Peanut OIT (study drug) is investigational because it is not currently approved for clinical use by the Food and Drug Administration. There are no alternative safe and effective treatments for peanut induced allergic reactions other than peanut avoidance and treatment with medications.
Interventions
- BIOLOGICAL Peanut Oral Immunotherapy (POIT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-07-31 |
| Est. Completion | 2020-02-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02203799
The ClinicalTrials.gov registry entry for NCT02203799 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Peanut Oral Immunotherapy (POIT) is the first listed.
NCT02203799 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02203799 about?
NCT02203799 is a clinical study titled "Peanut Oral Immunotherapy in Children With Peanut Allergy (Peanut Flour)". Many children who are allergic to peanuts do not outgrow their allergy and have very severe allergic reactions called anaphylaxis. Symptoms of anaphylaxis include difficulty breathing, decreased blood pressure, hives, and lip or throat swelling after exposure to an allergen. A severe allergic reacti...
What is the current status of trial NCT02203799?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2014-07-31. Estimated completion is 2020-02-11.
What interventions are being tested in trial NCT02203799?
The interventions under investigation include: Peanut Oral Immunotherapy (POIT) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02203799?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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