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Oral Peanut Immunotherapy (PNOIT)

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ClinicalTrials.gov Identifier: NCT01324401
Recruitment Status : Completed
First Posted : March 29, 2011
Results First Posted : January 20, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Wayne G. Shreffler, MD, PhD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Peanut Allergy
Intervention Drug: Peanut flour OIT
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control - Crossover Peanut OIT
Hide Arm/Group Description The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy. Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
Period Title: Overall Study
Started 4 26 [1]
Completed 3 [2] 20 [3]
Not Completed 1 6
Reason Not Completed
Withdrawn before any treatment             0             3
Adverse Event             1             3
[1]
3 excluded from ITT analysis: 1 screen fail, 2 voluntary withdrawal pre-treatment
[2]
one (1) could not tolerate minimum starting dose
[3]
three (3) unable to complete due to adverse events
Arm/Group Title Control - Crossover Peanut OIT Total
Hide Arm/Group Description The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will have the opportunity to cross over to active therapy. Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly. Total of all reporting groups
Overall Number of Baseline Participants 4 26 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 26 participants 30 participants
<=18 years
4
 100.0%
26
 100.0%
30
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 26 participants 30 participants
Female
1
  25.0%
11
  42.3%
12
  40.0%
Male
3
  75.0%
15
  57.7%
18
  60.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 26 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
2
   7.7%
2
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
3
  75.0%
23
  88.5%
26
  86.7%
More than one race
1
  25.0%
1
   3.8%
2
   6.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 26 participants 30 participants
4 26 30
1.Primary Outcome
Title Tolerance or Sustained Unresponsiveness
Hide Description The consumption of 5 grams of peanut protein during a double-blind placebo controlled food challenge without objective symptoms after one month of post treatment avoidance
Time Frame at least 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control - Crossover Peanut OIT
Hide Arm/Group Description:
The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
Overall Number of Participants Analyzed 4 23
Measure Type: Count of Participants
Unit of Measure: Participants
2
  50.0%
7
  30.4%
2.Secondary Outcome
Title Desensitization
Hide Description The consumption of 5 grams of peanut protein during an open food challenge without objective symptoms immediately post treatment
Time Frame at least 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control - Crossover Peanut OIT
Hide Arm/Group Description:
The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
Overall Number of Participants Analyzed 4 23
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
19
  82.6%
Time Frame From Oct 2011 to July 2014
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control - Crossover Peanut OIT
Hide Arm/Group Description The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy. Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
All-Cause Mortality
Control - Crossover Peanut OIT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control - Crossover Peanut OIT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/23 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control - Crossover Peanut OIT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      23/23 (100.00%)    
Gastrointestinal disorders     
GI: Abdominal Pain  1  4/4 (100.00%)  39 21/23 (91.30%)  191
Immune system disorders     
Allergy: Skin/Oral pruritis * 1  4/4 (100.00%)  68 18/23 (78.26%)  118
Allergy: Multiple Symptoms  1  4/4 (100.00%)  18 22/23 (95.65%)  215
Respiratory, thoracic and mediastinal disorders     
Resp: Wheeze/SOB  1  2/4 (50.00%)  4 10/23 (43.48%)  19
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Wayne Shreffler
Organization: Harvard Medical School / Massachusetts General Hospital
Phone: 617-726-6147
Responsible Party: Wayne G. Shreffler, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01324401     History of Changes
Other Study ID Numbers: 2010P000609
First Submitted: August 12, 2010
First Posted: March 29, 2011
Results First Submitted: November 23, 2016
Results First Posted: January 20, 2017
Last Update Posted: August 8, 2018