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NCT00932282 · ClinicalTrials.gov registry record · Phase 1
Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy
A Phase 1 study of Peanut Hypersensitivity, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT00932282: Completed Phase 1 study of Peanut Hypersensitivity, sponsored by University of North Carolina, Chapel Hill.
NCT00932282 is a Phase 1 study of Peanut Hypersensitivity that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 13 participants, below the 49-participant average among 3 other Peanut Hypersensitivity trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00932282, a Phase 1 study of Peanut Hypersensitivity, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine whether the addition of anti-IgE treatment will make peanut oral immunotherapy safer, more tolerable, and more effective in treating peanut allergy.
Primary Outcome
The primary efficacy outcome of the study is to evaluate whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy is able to induce clinical tolerance as measured by passing an oral food challenge to 20 grams of peanut flour, 2-4 weeks after discontinuing peanut OIT therapy
Conditions Studied
Interventions
- DRUG Omalizumab
- DRUG Peanut Oral Immunotherapy
Study Locations (1)
North Carolina
- University of North Carolina - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2009-07 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
What the finished NCT00932282 record still lists
NCT00932282 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 49-participant average among 3 other Peanut Hypersensitivity trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Peanut Hypersensitivity appearing as the primary indexed condition, and to 2 interventions - of which Omalizumab is the first listed.
NCT00932282 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00932282 about?
NCT00932282 is a clinical study titled "Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy". The purpose of this study is to determine whether the addition of anti-IgE treatment will make peanut oral immunotherapy safer, more tolerable, and more effective in treating peanut allergy.
What is the current status of trial NCT00932282?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2009-07. Estimated completion is 2015-08.
What conditions does trial NCT00932282 study?
This clinical trial studies the following conditions: Peanut Hypersensitivity.
What interventions are being tested in trial NCT00932282?
The interventions under investigation include: Omalizumab (DRUG), Peanut Oral Immunotherapy (DRUG).
Who is sponsoring clinical trial NCT00932282?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00932282 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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