Trials / Completed
CompletedNCT01891136
Oral Peanut Immunotherapy for Peanut Allergic Patients
Pilot Study: Oral Peanut Immunotherapy for Peanut Allergic Patients
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- University of North Carolina, Chapel Hill · Academic / Other
- Sex
- All
- Age
- 1 Year – 16 Years
- Healthy volunteers
- Not accepted
Summary
This is a study to determine if peanut oral immunotherapy (OIT) would desensitize or tolerize peanut allergic patients to peanuts in order prevent peanut allergic reactions.
Detailed description
The goal of this proposal is to develop peanut OIT for patients with peanut allergic reactions. This approach is designed to utilize our extensive knowledge of the allergens involved in peanut hypersensitivity to devise an immunotherapeutic approach that would lower the risk of anaphylactic reactions and would down regulate peanut-specific T cells in peanut-allergic patients. Previous attempts to utilize peanut-specific immunotherapy (IT) have been unsuccessful primarily because of the side effects of therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Peanut protein | Subjects will receive increasing amounts of peanut protein over the modified rush phase and the build-up phase of the protocol. Once the subject reaches the maintenance phase of the study, they will remain on that dose until they reach the oral food challenges at the end of the study. |
Timeline
- Start date
- 2004-04-01
- Primary completion
- 2014-11-01
- Completion
- 2014-12-01
- First posted
- 2013-07-02
- Last updated
- 2015-06-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01891136. Inclusion in this directory is not an endorsement.