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NCT01867671 · ClinicalTrials.gov registry record · Phase 2
Peanut Oral Immunotherapy in Children
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 146
- Enrollment target
NCT01867671: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01867671 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 146 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01867671, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 146 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in peanut-allergic children. Eligible participants with peanut allergy will be randomly assigned to receive either peanut OIT or placebo for 134 weeks followed by peanut avoidance for 26 weeks.
Primary Outcome
Definition of desensitized to peanut: A participant who passed the blinded (masked) oral food challenge (OFC) to10 grams of peanut flour (=5 grams of peanut protein) without significant symptoms.\* \*Significant symptoms include hives, wheezing, vomiting, or laryngeal edema.
Interventions
- BIOLOGICAL Peanut Oral Immunotherapy - Liquid Extract
- BIOLOGICAL Placebo for Peanut Oral Immunotherapy - Liquid Extract form
- BIOLOGICAL Peanut Oral Immunotherapy - Peanut Flour
- BIOLOGICAL Placebo for Peanut Oral Immunotherapy - Peanut Flour
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2013-08-13 |
| Est. Completion | 2018-12-21 |
| Phase | Phase 2 |
What the finished NCT01867671 record still lists
NCT01867671 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 4 interventions - of which Peanut Oral Immunotherapy - Liquid Extract is the first listed.
NCT01867671 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01867671 about?
NCT01867671 is a clinical study titled "Peanut Oral Immunotherapy in Children". This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in peanut-allergic children. Eligible participants with peanut allergy will be randomly assigned to receive either peanut ...
What is the current status of trial NCT01867671?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 146 participants. The study started on 2013-08-13. Estimated completion is 2018-12-21.
What interventions are being tested in trial NCT01867671?
The interventions under investigation include: Peanut Oral Immunotherapy - Liquid Extract (BIOLOGICAL), Placebo for Peanut Oral Immunotherapy - Liquid Extract form (BIOLOGICAL), Peanut Oral Immunotherapy - Peanut Flour (BIOLOGICAL), Placebo for Peanut Oral Immunotherapy - Peanut Flour (BIOLOGICAL).
Who is sponsoring clinical trial NCT01867671?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01867671's enrollment target sits among peer trials
146 496th of 2000 higher than 1,503 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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