Clinical Trials Directory

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

TypeNameDescription
DRUGPeanut proteinSubjects 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.