Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study (DEVIL)
|ClinicalTrials.gov Identifier: NCT00932828|
Recruitment Status : Completed
First Posted : July 3, 2009
Last Update Posted : July 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Food Hypersensitivity||Drug: Low Dose Peanut Protein Drug: High Dose Peanut Protein||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study; Grant "Optimizing Tolerance Induction in Peanut Allergy: The DEVIL Study"|
|Actual Study Start Date :||June 22, 2009|
|Primary Completion Date :||February 1, 2017|
|Study Completion Date :||February 1, 2017|
Experimental: Low dose peanut protein
Subject will be randomized to receive a low dose of peanut protein mixed with a placebo protein.
Drug: Low Dose Peanut Protein
Peanut flour mixed with placebo will be given in gradually increasing doses.
Other Name: Peanut and placebo flour
Experimental: High dose peanut protein
Subject will be randomized to receive a high dose of peanut protein.
Drug: High Dose Peanut Protein
Peanut flour will be given in gradually increasing doses.
Other Name: Peanut protein flour
No Intervention: Historical Control
This group will be followed for the same amount of time as the active subjects, to observe the natural history of peanut allergy.
- To treat peanut-allergic subjects with PMIT and to determine whether this protocol lowers their risk of anaphylactic reactions and causes long-term tolerance. [ Time Frame: 4 years ]
- To determine the effect that PMIT has on the peanut-specific cellular and humoral response in peanut-allergic subjects. [ Time Frame: 4 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932828
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Arvil W Burks, MD||University of North Carolina|