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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: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT02203799 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Patients underwent a build-up phase (month 0-12). The patients returned every 2 weeks during the build-up phase until the maintenance dose of 3900 mg was achieved. The 12-month double blind placebo controlled food challenge (DBPFC) was performed on achieving the maintenance dose. The primary objective was to determine the percentage of subjects tolerating a cumulative dose of 26255 mg of peanut flour with absence of clinical symptoms during the 12-month DBPCFC.
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 |
What the finished NCT02203799 record still lists
NCT02203799 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which Peanut Oral Immunotherapy (POIT) is the first listed.
NCT02203799 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02203799's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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