Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study (DEVIL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||February 1, 2017|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|