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Peanut Oral Immunotherapy (OIT) - Initial Pilot Study in Adults

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ClinicalTrials.gov Identifier: NCT01274429
Recruitment Status : Terminated (Lack of funding)
First Posted : January 11, 2011
Results First Posted : March 10, 2017
Last Update Posted : March 27, 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: Peanut Allergy
Intervention: Drug: Peanut flour

  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
Open Label Peanut Flour Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.

Participant Flow:   Overall Study
    Open Label Peanut Flour
STARTED   5 
COMPLETED   0 
NOT COMPLETED   5 
Study closed do to lack of funding                5 



  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
Open Label Peanut Flour

Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.

Peanut flour: Peanut flour that is ingested daily and administered in gradually increasing amounts up to a maximum maintenance dose.


Baseline Measures
   Open Label Peanut Flour 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      5 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Full Range)
 19.5 
 (18.8 to 21.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      5 100.0% 
Region of Enrollment 
[Units: Participants]
 
United States   5 


  Outcome Measures

1.  Primary:   Determine Whether This Peanut OIT Protocol Lowers Their Risk of Anaphylactic Reactions and Causes Long-term Tolerance.   [ Time Frame: 2-3 years ]

2.  Secondary:   Determine the Effect That PNOIT Has on the Peanut-specific Cellular and Humoral Response in Peanut-allergic Subjects.   [ Time Frame: 2-3 years ]


  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
Early termination due to lack of funding prior to any subjects reaching the primary endpoint.


  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



Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01274429     History of Changes
Other Study ID Numbers: 11-2314
First Submitted: January 9, 2011
First Posted: January 11, 2011
Results First Submitted: January 21, 2017
Results First Posted: March 10, 2017
Last Update Posted: March 27, 2018