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Trial record 1 of 1 for:    Peanut Reactivity Reduced by Oral Tolerance in an anti-IgE Clinical
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Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial (PRROTECT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Stanford University
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Lynda Schneider, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT01781637
First received: January 30, 2013
Last updated: May 2, 2017
Last verified: May 2017
Results First Received: March 23, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Conditions: Peanut Allergy
Food Allergy
Interventions: Drug: Omalizumab
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Omalizumab Group

Patients will receive omalizumab.

Omalizumab: subcutaneous injection

Placebo

Patients will receive placebo.

placebo: subcutaneous injection


Participant Flow:   Overall Study
    Omalizumab Group   Placebo
STARTED   28   8 
COMPLETED   24   2 
NOT COMPLETED   4   6 
Adverse Event                1                0 
Lack of Efficacy                2                6 
Withdrawal by Subject                1                0 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Omalizumab Group

Patients will receive omalizumab.

Omalizumab: subcutaneous injection

Placebo

Patients will receive placebo.

placebo: subcutaneous injection

Total Total of all reporting groups

Baseline Measures
   Omalizumab Group   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   8   37 
Age 
[Units: Years]
Median (Full Range)
 10 
 (7 to 19) 
 10 
 (6 to 17) 
 10 
 (6 to 19) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11  37.9%      4  50.0%      15  40.5% 
Male      18  62.1%      4  50.0%      22  59.5% 
Baseline population [1] 
[Units: Participants]
Count of Participants
 29   8   37 
[1] One subject declined treatment after being randomized but before beginning treatment


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo   [ Time Frame: 6 weeks after last dose of omalizumab/placebo ]

2.  Secondary:   Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo   [ Time Frame: 12 weeks after last dose of omalizumab/placebo ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  More Information
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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: Lynda Schneider
Organization: Boston Children's Hospital
phone: 617-355-6180
e-mail: lynda.schneider@childrens.harvard.edu



Responsible Party: Lynda Schneider, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT01781637     History of Changes
Other Study ID Numbers: Peanut 002
Study First Received: January 30, 2013
Results First Received: March 23, 2017
Last Updated: May 2, 2017