Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study (DEVIL)
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|ClinicalTrials.gov Identifier: NCT00932828|
Recruitment Status : Completed
First Posted : July 3, 2009
Results First Posted : May 24, 2018
Last Update Posted : May 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Food Hypersensitivity||Drug: Peanut oral immunotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||For the purposes of the primary outcome, all subjects will receive peanut OIT and represent a single group. For exploratory analysis, subjects will be randomized to high and low dose OIT to potentially look for a dose response.|
|Masking:||None (Open Label)|
|Masking Description:||For exploratory analysis, subjects will be randomized 1:1 to high (3000mg) and low dose (300mg) OIT to potentially look for a dose response. Low dose will be masked by adding oat flour to provide a dose equal to high dose with respect to flour but with lower peanut protein content|
|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: Peanut oral immunotherapy
Newly diagnosed allergic children receiving peanut flour as oral immunotherapy for the treatment of peanut allergy.
Drug: Peanut oral immunotherapy
Defatted peanut in flour form to be used as treatment for peanut allergy
- Determine the Percentage of Subjects Who Demonstrate Sustained Unresponsiveness (SU) by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC). [ Time Frame: After 36 months of OIT dosing followed by 1 month of avoidance ]The goal of the study is to treat peanut-allergic subjects with peanut OIT and to determine whether this protocol lowers their risk of anaphylactic reactions and causes SU. We expect to demonstrate the effectiveness of peanut OIT in inducing SU by showing that subjects will have a negative DBPCFC to 5 grams of peanut following completion of a 36-month course of peanut OIT followed by avoidance of therapy for 4 weeks.
- Determine the Percentage of Subjects Who Demonstrate Desensitization by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC). [ Time Frame: After 36 months of OIT dosing ]We expect to demonstrate the effectiveness of peanut OIT in inducing desensitization by showing that subjects will have a negative DBPCFC to 5 grams of peanut following completion of a 36-month course of peanut OIT .
- Determine the Frequency of Treatment-related Adverse Effects (TAE) From Peanut OIT. [ Time Frame: After 36 months of OIT dosing followed by 1 month of avoidance ]In addition to studying the effectiveness of peanut OIT, we will also determine the safety of peanut OIT by reporting the average rate of TAEs per person per dose.
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|