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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
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Prospective Phase 1 clinical trial providing proof of concept data on boiled peanut oral immunotherapy (OIT) for the treatment of peanut allergy in children. The investigators hypothesize that the proportion of subjects successfully desensitized with boiled peanut OIT is greater than the theoretical placebo rate of 20%.
Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. Participants will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. Participants will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit double blind placebo controlled food challenge. At the conclusion of the study, participants will be offered continued maintenance therapy off study in line with current specialty standards.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boiled Peanut Powder | Experimental | Boiled Peanut Powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boiled Peanut Powder | Drug | Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. The subjects will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. The subjects will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit DBPCFC. At the conclusion of the study, patients will be offered continued maintenance therapy off study in line with current specialty standards. |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in Tolerance to Peanut in Pediatric Patients With Peanut Hypersensitivity Reported as the Percentage of Participants Successfully Desensitized. | The percentage of patients able to consume a single dose of 300 mg or greater of peanut protein with no dose limiting symptoms at exit food challenge are considered 'successfully desensitized'. Any enrolled participants who did not tolerate the 300 mg dose or did not complete the exit food challenge for any reason are considered not successfully desensitized. The percentage of successfully desensitized participants is presented with corresponding lower bound of the one-sided 95% CI, calculated as the lower bound of a two-sided 90% exact confidence interval. | 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaclyn Bjelac, MD | Staff | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Boiled Peanut Powder | Boiled Peanut Powder Boiled Peanut Powder: Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. The subjects will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. The subjects will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit DBPCFC. At the conclusion of the study, patients will be offered continued maintenance therapy off study in line with current specialty standards. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Boiled Peanut Powder | Boiled Peanut Powder Boiled Peanut Powder: Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. The subjects will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. The subjects will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit DBPCFC. At the conclusion of the study, patients will be offered continued maintenance therapy off study in line with current specialty standards. |
| 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 | Increase in Tolerance to Peanut in Pediatric Patients With Peanut Hypersensitivity Reported as the Percentage of Participants Successfully Desensitized. | The percentage of patients able to consume a single dose of 300 mg or greater of peanut protein with no dose limiting symptoms at exit food challenge are considered 'successfully desensitized'. Any enrolled participants who did not tolerate the 300 mg dose or did not complete the exit food challenge for any reason are considered not successfully desensitized. The percentage of successfully desensitized participants is presented with corresponding lower bound of the one-sided 95% CI, calculated as the lower bound of a two-sided 90% exact confidence interval. | All participants who enrolled in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | 18 weeks |
|
All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
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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 | Boiled Peanut Powder | Boiled Peanut Powder Boiled Peanut Powder: Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. The subjects will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. The subjects will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit DBPCFC. At the conclusion of the study, patients will be offered continued maintenance therapy off study in line with current specialty standards. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylaxis - Hives; redness and swelling of eyes; cough; difficulty breathing | Immune system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
Enrollment was paused due to institutional IRB regulations during the COVID-19 pandemic. After resumption of enrollment, the study proceeded as planned.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jaclyn Bjelac | Cleveland Clinic | 216 445-1449 | bjelacj2@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 12, 2020 | Jul 31, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2022 | Jul 31, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 6, 2020 | Jul 31, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Prospective open label phase I
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| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| 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 | Count of Participants | Participants |
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| 0 |
| 8 |
| 2 |
| 8 |
| 8 |
| 8 |
| Coughing and wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Globus sensation; audible change in voice; dysphagia | Immune system disorders | Systematic Assessment |
|
| Abdominal Pain, Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain, Facial Flushing, Head Pain, Pruritus, Malaise | Immune system disorders | Systematic Assessment |
|
| Abdominal Pain, Non-Cardiac Chest Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain, Upset Stomach, Reflux | Gastrointestinal disorders | Systematic Assessment |
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| Belching | Gastrointestinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough, Urticaria, Lip/Mouth Pruritus, Vomiting | Immune system disorders | Systematic Assessment |
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| Cough, Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Eczema, Pruritus | Immune system disorders | Systematic Assessment |
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| Eczema, Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Eyelid Dysfunction (Redness/Swelling) | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Facial Rash, Mucositis Oral | Immune system disorders | Systematic Assessment |
|
| Fever, Vomiting | Infections and infestations | Systematic Assessment |
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| Gastrointestinal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Lip/Mouth Pruritus | Immune system disorders | Systematic Assessment |
|
| Lip/Mouth Pruritus, Abdominal Pain, Throat Pruritus | Immune system disorders | Systematic Assessment |
|
| Lip/Mouth Pruritus, Eye Pruritus, Vomiting | Immune system disorders | Systematic Assessment |
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| Lip/Mouth Pruritus, Nausea | Immune system disorders | Systematic Assessment |
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| Lip/Mouth Pruritus, Rash Maculo-Papular | Immune system disorders | Systematic Assessment |
|
| Lip/Mouth Pruritus, Throat Pruritus | Immune system disorders | Systematic Assessment |
|
| Lip/Mouth Pruritus, Throat Pruritus, Nausea | Immune system disorders | Systematic Assessment |
|
| Nasal Congestion, Urticaria | Immune system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Pruritus | Immune system disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus, Cough | Immune system disorders | Systematic Assessment |
|
| Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinitis | General disorders | Systematic Assessment |
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| Rhinitis, Nasal Congestion | General disorders | Systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Serous Otitis | Ear and labyrinth disorders | Systematic Assessment |
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| Throat Pruritus | Immune system disorders | Systematic Assessment |
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| Urticaria | Immune system disorders | Systematic Assessment |
|
| Urticaria, Cough | Immune system disorders | Systematic Assessment |
|
| Urticaria, Eye Pruritus, Nasal Congestion | Immune system disorders | Systematic Assessment |
|
| Urticaria, Periorbital Edema | Immune system disorders | Systematic Assessment |
|
| Urticaria, Rash Maculo-Papular | Immune system disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting, Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting, Nasal Congestion, Chest Wall Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting, Urticaria | Immune system disorders | Systematic Assessment |
|
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