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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
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Food Hypersensitivity
Intervention: Drug: Peanut oral immunotherapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Peanut Oral Immunotherapy All subjects are treated with peanut oral immunotherapy for primary outcome. Patients randomized to 300mg or 3000mg for secondary dose finding outcome.

Participant Flow:   Overall Study
    Peanut Oral Immunotherapy
STARTED   37 
COMPLETED   32 [1] 
NOT COMPLETED   5 
[1] 5 subjects who did not complete the protocol were considered in an ITT analysis.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Peanut Oral Immunotherapy All subjects who are treated with peanut OIT (300mg or 3000mg) and undergo a DBPCFC after 36 months of treatment and an additional DBPCFC after 4 weeks of treatment avoidance. Analysis was completed ITT.

Baseline Measures
   Peanut Oral Immunotherapy 
Overall Participants Analyzed 
[Units: Participants]
 37 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      37 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age 
[Units: Months]
Median (Inter-Quartile Range)
 28.5 
 (22 to 35) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      12  32.4% 
Male      25  67.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   2.7% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      3   8.1% 
White      33  89.2% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   37 
Peanut immunoglobin E (IgE) 
[Units: kUA/L]
Median (Inter-Quartile Range)
 14.4 
 (3.4 to 48.6) 
Peanut skin prick test (SPT) [1] 
[Units: Mm wheal size]
Median (Inter-Quartile Range)
 11.5 
 (8 to 16.5) 
[1] Epicutaneous skin prick test applied using the Greer pick and measured after 15 minutes. Cross diameters of the raised wheal skin response are averaged and reported as the average wheal size in mm.


  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Edwin Kim, Director of the UNC Food Allergy Initiative
Organization: University of North Carolina at Chapel Hill
phone: 919-843-9087
e-mail: edwinkim@email.unc.edu


Publications of Results:

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00932828     History of Changes
Other Study ID Numbers: 11-2307
First Submitted: July 2, 2009
First Posted: July 3, 2009
Results First Submitted: February 1, 2018
Results First Posted: May 24, 2018
Last Update Posted: May 24, 2018