NCT02203799|CompletedPhase 1ResultsDMC
Peanut Oral Immunotherapy in Children With Peanut Allergy (Peanut Flour)
PeanutFlour
Immune Responses in Peanut Allergic Subjects Undergoing Peanut Oral Immunotherapy
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Sponsor study identifier
interventional
15
1 country
1
Study Start
July 31, 2014
Actual (reported)Primary Completion
February 11, 2020
Actual (reported)Study Completion
February 11, 2020
Actual (reported)Many children who are allergic to peanuts do not outgrow their allergy and have very severe allergic reactions called anaphylaxis. Symptoms of anaphylaxis include difficulty breathing, decreased blood pressure, hives, and lip or throat swelling after exposure to an allergen. A severe allergic reaction can lead to death if not treated appropriately. The purpose of this study is to find out if there is a way to treat children with peanut allergy to help lower the risk of severe allergic reactions and also cause them to lose their allergy to peanuts. The approach that will used for this study is a process called "desensitization". Oral immunotherapy involves eating gradually increasing amounts of a food over several months. This is a research study because at this time peanut oral immunotherapy (OIT) is investigational. Peanut OIT (study drug) is investigational because it is not currently approved for clinical use by the Food and Drug Administration. There are no alternative safe and effective treatments for peanut induced allergic reactions other than peanut avoidance and treatment with medications.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 11, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 28, 2014
Actual (reported)July 30, 2014
Actual (reported)July 31, 2014
Actual (reported)February 11, 2020
Actual (reported)February 11, 2020
Actual (reported)January 19, 2024
Actual (reported)Determine the Percentage of Patients Tolerating the 12-month DBPCFC
Patients underwent a build-up phase (month 0-12). The patients returned every 2 weeks during the build-up phase until the maintenance dose of 3900 mg was achieved. The 12-month double blind placebo controlled food challenge (DBPFC) was performed on achieving the maintenance dose. The primary objective was to determine the percentage of subjects tolerating a cumulative dose of 26255 mg of peanut flour with absence of clinical symptoms during the 12-month DBPCFC.
Month 12 after first dose of peanut flour
Sustained Unresponsiveness After 1 Month of Treatment Discontinuation
Month 36 and 37 after first dose of peanut flour
The peanut OIT is taken in the form of peanut flour. It will be given in small cups containing the amount of flour that needs to be eaten for one dose. One dose should be taken per day.
The peanut protein is ingested in the form of peanut flour. Peanut flour will be given in small pre-measured soufflé cups containing the amount of peanut flour that needs to be eaten for one dose. One dose will be taken per day. Dosage of the peanut flour will begin with 1.8 mg of peanut protein during the initial visit or the lowest tolerated dose on initial challenge and increased every 2 during the build-up phase until the maintenance dose of peanut protein (3900 mg) is reached.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Texas Children's Hospital
Houston, Texas, 77030, United States
Carla M Davis, MD
Texas Children's Hospital/Baylor College of Medicine
15 participants (actual enrollment reported by the registry).
First Submitted
July 28, 2014
First Posted
July 30, 2014
Study Start
July 31, 2014
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
February 11, 2020
Actual (reported)Study Completion
February 11, 2020
Actual (reported)Last Updated
January 19, 2024
Results First Posted
January 19, 2024
Record last verified: 2023-04
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Source: ClinicalTrials.gov.
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