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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI068074 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The purpose of this study is to attempt to understand how desensitization works in peanut allergic children who are undergoing oral immunotherapy (OIT) to peanut. We want to identify the early changes in the desensitization process the immune cells undergo to become desensitized to the peanut protein.
Peanut allergic children will undergo an oral food challenge (OFC) to 1 gm peanut protein in order to accomplish two objectives: (1)to confirm the diagnosis of peanut allergy, and (2) to measure the amount of peanut protein it takes to cause an allergic reaction. Each subject will then undergo a modified rush phase in which the subject receives 6 doses of peanut protein in one day. The build-up phase begins afterward in which the subject's dose of peanut protein is increased every 2 weeks for 36 weeks. After the final build-up dose, the subject consumes that dose for 2 weeks after which he or she returns to the food allergy center for the second food challenge. If the subject successfully consumes this food challenge without symptoms, the daily dosing of peanut protein will be stopped and the subject will then undergo a third food challenge. If the subject successfully consumes the peanut protein during that challenge, he or she will return for a fourth food challenge to peanut.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label peanut OIT | Experimental | Open label orally ingested peanut flour with maintenance dose of 1450mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open label peanut OIT | Drug | Subject will take increasing amounts of peanut protein up to a maximum maintenace dose of 1450mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Develop Desensitization | The percentage of peanut allergic subjects who develop desensitization as defined by being able to consume 5000mg of peanut protein during a double blind food challenge after completing a build-up phase of peanut OIT. | 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Maintain Desensitization Once OIT is Stopped | The percentage of subjects who maintain desensitization once the OIT is withdrawn at 1, 2, 3, and 4 week intervals. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Wheal Diameter, as Assessed by the Skin Prick Test (SPT) to Peanut | Allergic reactivity of mast cells is assessed by skin prick testing through measurement of the wheal diameter after exposure to peanut. This outcome measure reports the change in skin prick test wheal diameter from baseline through the end of the treatment period. | 44 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wesley Burks, MD | UNC Chapel Hill | Principal Investigator |
| Edwin Kim, MD | UNC Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label Peanut OIT | Open label orally ingested peanut flour with maintenance dose of 1450mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label Peanut OIT | Open label orally ingested peanut flour with maintenance dose of 1450mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Who Develop Desensitization | The percentage of peanut allergic subjects who develop desensitization as defined by being able to consume 5000mg of peanut protein during a double blind food challenge after completing a build-up phase of peanut OIT. | Posted | Number | percentage of participants | 40 weeks |
|
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31 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label Peanut OIT | Open label orally ingested peanut flour with maintenance dose of 1450mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Edwin Kim, Director of the UNC Food Allergy Initiative | University of North Carolina at Chapel Hill | 919-843-9087 | edwinkim@email.unc.edu |
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| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000074924 | Nut and Peanut Hypersensitivity |
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| Change in Peanut Specific Immunoglobin E (IgE) From Baseline Until Desensitization Food Challenge | The investigation of mechanistic changes that occur in the immune system over the duration of the study - Peanut specific immunoglobin E (IgE) | 44 weeks |
| Change in Immunoglobin G4 (IgG4) to Peanut From Baseline Until Desensitization Food Challenge | The investigation of mechanistic changes that occur in the immune system dover the duration of the study - Immunoglobin G4 (IgG4) to peanut | 44 weeks |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Percentage of Subjects Who Maintain Desensitization Once OIT is Stopped | The percentage of subjects who maintain desensitization once the OIT is withdrawn at 1, 2, 3, and 4 week intervals. | Posted | Number | percentage of participants | 4 weeks |
|
|
|
| Other Pre-specified | Change From Baseline in the Wheal Diameter, as Assessed by the Skin Prick Test (SPT) to Peanut | Allergic reactivity of mast cells is assessed by skin prick testing through measurement of the wheal diameter after exposure to peanut. This outcome measure reports the change in skin prick test wheal diameter from baseline through the end of the treatment period. | Posted | Mean | Full Range | mm | 44 weeks |
|
|
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| Other Pre-specified | Change in Peanut Specific Immunoglobin E (IgE) From Baseline Until Desensitization Food Challenge | The investigation of mechanistic changes that occur in the immune system over the duration of the study - Peanut specific immunoglobin E (IgE) | Blood work was not able to be obtained from 1 of 16 evaluable subjects | Posted | Median | Full Range | kU/L of peanut-specific IgE | 44 weeks |
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|
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| Other Pre-specified | Change in Immunoglobin G4 (IgG4) to Peanut From Baseline Until Desensitization Food Challenge | The investigation of mechanistic changes that occur in the immune system dover the duration of the study - Immunoglobin G4 (IgG4) to peanut | Blood work was not able to be obtained from 1 of 16 evaluable subjects | Posted | Median | Full Range | mg/dL of IgG4 | 44 weeks |
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| 0 |
| 20 |
| 0 |
| 20 |
| 15 |
| 20 |
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Erythematous rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Oropharyngeal itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Itchy nose | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin itch | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Lip or eye swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Eye itch | Eye disorders | Systematic Assessment |
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| Eye tearing | Eye disorders | Systematic Assessment |
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| Hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Throat tightness | Gastrointestinal disorders | Systematic Assessment |
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