We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy (PAIE/Xolair)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00932282
First Posted: July 3, 2009
Last Update Posted: September 26, 2017
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.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
Results First Submitted: July 31, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Peanut Hypersensitivity
Interventions: Drug: Peanut Oral Immunotherapy
Drug: Omalizumab

  Participant Flow
  Hide Participant Flow

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
12 Month Maintenance of PnOIT Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
24 Month Maintenance of PnOIT Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.

Participant Flow for 4 periods

Period 1:   Pre-OIT Anti-IgE Therapy Phase
    12 Month Maintenance of PnOIT   24 Month Maintenance of PnOIT
STARTED   7   6 
COMPLETED   6   5 
NOT COMPLETED   1   1 

Period 2:   Modified OIT Rush Desensitization Phase
    12 Month Maintenance of PnOIT   24 Month Maintenance of PnOIT
STARTED   6   5 
COMPLETED   6   5 
NOT COMPLETED   0   0 

Period 3:   Biweekly OIT Buildup Phase
    12 Month Maintenance of PnOIT   24 Month Maintenance of PnOIT
STARTED   6   5 
COMPLETED   5   4 
NOT COMPLETED   1   1 

Period 4:   OIT Maintenance Phase
    12 Month Maintenance of PnOIT   24 Month Maintenance of PnOIT
STARTED   5   4 
COMPLETED   4   2 
NOT COMPLETED   1   2 



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
12 Month Maintenance of PnOIT Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
24 Month Maintenance of PnOIT Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
Total Total of all reporting groups

Baseline Measures
   12 Month Maintenance of PnOIT   24 Month Maintenance of PnOIT   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   6   13 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      6  85.7%      6 100.0%      12  92.3% 
Between 18 and 65 years      1  14.3%      0   0.0%      1   7.7% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Median (Full Range)
 14.4 
 (12.6 to 19.9) 
 14.1 
 (12.8 to 16.1) 
 14.4 
 (12.6 to 19.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  42.9%      3  50.0%      6  46.2% 
Male      4  57.1%      3  50.0%      7  53.8% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   7   6   13 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Percentage of Subjects Who Pass the 20gm Peanut Flour (~50% Peanut Protein) Oral Food Challenge 2-4 Weeks After Discontinuing Peanut OIT Therapy   [ Time Frame: approximately 24 or 36 months ]

2.  Secondary:   The Percentage of Subjects Who Tolerate the Initial Desensitization Day(s) to 950mg of Peanut Flour.   [ Time Frame: 4 months ]

3.  Secondary:   The Percentage of Subjects Who Pass the 20gm Peanut Flour (~50% Peanut Protein) Oral Food Challenge Following the Desensitization Phase of the Study   [ Time Frame: approximately 24 or 36 months ]

4.  Secondary:   Incidence of All Serious Adverse Events During the Study   [ Time Frame: approximately 24 or 36 months ]

5.  Secondary:   Incidence of Side Effects During Initial Escalation and Build up Phase of Peanut Oral Immunotherapy   [ Time Frame: approximately 24 or 36 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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: Edwin Kim, Director UNC Food Allergy Initiative
Organization: University of North Carolina at Chapel Hill
phone: 919-843-9087
e-mail: edwinkim@email.unc.edu



Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00932282     History of Changes
Other Study ID Numbers: 11-2306
First Submitted: June 10, 2009
First Posted: July 3, 2009
Results First Submitted: July 31, 2017
Results First Posted: September 26, 2017
Last Update Posted: September 26, 2017



To Top