Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-02-26 @ 2:15 AM
Study NCT ID:
NCT04090203
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2019-05-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Boiled Peanut Oral Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D021183', 'term': 'Peanut Hypersensitivity'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D000074924', 'term': 'Nut and Peanut Hypersensitivity'}, {'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007167', 'term': 'Immunotherapy'}], 'ancestors': [{'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bjelacj2@ccf.org', 'phone': '216 445-1449', 'title': 'Dr. Jaclyn Bjelac', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Enrollment was paused due to institutional IRB regulations during the COVID-19 pandemic. After resumption of enrollment, the study proceeded as planned.'}}, 'adverseEventsModule': {'timeFrame': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Boiled Peanut Powder', 'description': 'Boiled Peanut Powder\n\nBoiled 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.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 9, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain, Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain, Facial Flushing, Head Pain, Pruritus, Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain, Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain, Upset Stomach, Reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Belching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough, Urticaria, Lip/Mouth Pruritus, Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough, Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 8, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eczema, Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eczema, Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eyelid Dysfunction (Redness/Swelling)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Facial Rash, Mucositis Oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever, Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lip/Mouth Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 48, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lip/Mouth Pruritus, Abdominal Pain, Throat Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lip/Mouth Pruritus, Eye Pruritus, Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lip/Mouth Pruritus, Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lip/Mouth Pruritus, Rash Maculo-Papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lip/Mouth Pruritus, Throat Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lip/Mouth Pruritus, Throat Pruritus, Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Congestion, Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus, Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinitis, Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Serous Otitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Throat Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 11, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria, Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria, Eye Pruritus, Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria, Periorbital Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria, Rash Maculo-Papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting, Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting, Nasal Congestion, Chest Wall Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting, Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anaphylaxis - Hives; redness and swelling of eyes; cough; difficulty breathing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coughing and wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Globus sensation; audible change in voice; dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Increase in Tolerance to Peanut in Pediatric Patients With Peanut Hypersensitivity Reported as the Percentage of Participants Successfully Desensitized.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Boiled Peanut Powder', 'description': 'Boiled Peanut Powder\n\nBoiled 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '100'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '75.0', 'ciLowerLimit': '40.0', 'pValueComment': 'The test was performed at a one-sided significance level of 0.05.', 'estimateComment': 'The percentage of successfully desensitized participants is presented with a one-sided 95% CI, obtained from the lower bound of the two-sided 90% Clopper-Pearson exact confidence interval.', 'groupDescription': 'The null hypothesis was that the percentage of patients who were successfully desensitized was less than or equal to 20%, and the alternative hypothesis was that this percentage was greater than 20%. Assuming 80% of study participants would be successfully desensitized, a sample size of 10 patients would provide greater than 90% power to reject the null hypothesis using a one-sided exact binomial test with a significance level of 0.05.', 'statisticalMethod': 'Exact binomial test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The null hypothesis of the exact binomial test was that the percentage of patients who were successfully desensitized was less than or equal to 20%.'}], 'paramType': 'NUMBER', 'timeFrame': '18 weeks', 'description': "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.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who enrolled in the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Boiled Peanut Powder', 'description': 'Boiled Peanut Powder\n\nBoiled 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Boiled Peanut Powder', 'description': 'Boiled Peanut Powder\n\nBoiled 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.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-12', 'size': 1411756, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-31T16:16', 'hasProtocol': True}, {'date': '2022-03-08', 'size': 899698, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-31T16:16', 'hasProtocol': False}, {'date': '2020-04-06', 'size': 370908, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-07-31T16:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective open label phase I'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-03', 'studyFirstSubmitDate': '2019-05-30', 'resultsFirstSubmitDate': '2023-08-15', 'studyFirstSubmitQcDate': '2019-09-12', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-03', 'studyFirstPostDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in Tolerance to Peanut in Pediatric Patients With Peanut Hypersensitivity Reported as the Percentage of Participants Successfully Desensitized.', 'timeFrame': '18 weeks', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peanut', 'Allergy'], 'conditions': ['Peanut Hypersensitivity']}, 'descriptionModule': {'briefSummary': '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%.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 1-16 years\n* History of immediate hypersensitivity reaction to peanut\n* Evidence of IgE mediated peanut hypersensitivity within a 12 month period of study enrollment\n* SPT with wheal/flare of at least 3 x 6 mm and/or Peanut specific IgE \\>0.35 kU/L\n\nExclusion Criteria:\n\n* History of life threatening peanut anaphylaxis\n* Asthma requiring more than medium dose ICS\n* Prior participation in oral immunotherapy, sublingual immunotherapy or epicutaneous immunotherapy\n* Oat allergy\n* Cardiovascular Disease\n* Use of beta-blockers (oral), angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or calcium channel blockers\n* Use of steroid medications in the following manners:\n* Daily oral steroid dosing for greater than 1 month during the past year\n* Burst or steroid course in the past 3 month before inclusion\n* Greater than 2 bursts oral steroid courses in the past year of at least 1 week duration\n* Pregnancy or lactation\n* Eosinophilic Gastrointestinal Disease\n* History of food protein-induced enterocolitis\n* History of developmental delay or speech delay that precludes age- appropriate communication, in the opinion of the investigator'}, 'identificationModule': {'nctId': 'NCT04090203', 'acronym': 'BPOIT', 'briefTitle': 'Boiled Peanut Oral Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergic Pediatric Patients', 'orgStudyIdInfo': {'id': 'BPOIT 18-1294'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Boiled Peanut Powder', 'description': 'Boiled Peanut Powder', 'interventionNames': ['Drug: Boiled Peanut Powder']}], 'interventions': [{'name': 'Boiled Peanut Powder', 'type': 'DRUG', 'otherNames': ['Immunotherapy'], 'description': '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.', 'armGroupLabels': ['Boiled Peanut Powder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Jaclyn Bjelac, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Staff'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alton Melton', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Cleveland Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor-Investigator', 'investigatorFullName': 'Alton Melton', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}