Status:
COMPLETED
Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study
Lead Sponsor:
Johns Hopkins University
Conditions:
Treatment Efficacy
Eligibility:
All Genders
4-9 years
Phase:
PHASE2
Brief Summary
This application is being submitted as a follow-up to Protocol "Oral Immunotherapy for Induction of Tolerance in Peanut Allergic Children-The IMPACT Study." The IMPACT study was a double-blind, placeb...
Detailed Description
This study will enroll up to 20 subjects aged 4-9 years old who were enrolled in the placebo arm of the IMPACT study. Once subjects have completed participation in the IMPACT study, subjects will be ...
Eligibility Criteria
Inclusion
- Patients who meet all of the following criteria are eligible for enrollment as study participants, including participants who:
- Subjects who were randomized to the placebo arm of protocol NA\_00077852 "Oral Immunotherapy for Induction of Tolerance in Peanut Allergic Children."
- Parent guardian must be able to understand and provide informed consent
- Peanut allergy, as defined by a reaction to a cumulative dose of ≤1000 mg of peanut protein during the End-of-Treatment food challenge from Protocol NA\_00077852 "Oral Immunotherapy for Induction of Tolerance in Peanut Allergic Children"
Exclusion
- Patients who meet any of these criteria are not eligible for enrollment as study participants, including participants who:
- Inability or unwillingness of a parent guardian to give written informed consent or comply with study protocol
- History of severe anaphylaxis to peanut, defined by severe hypoxia, hypotension, neurological compromise, confusion, cardiovascular collapse, or loss of consciousness
- Significant chronic disease (other than asthma, rhinitis, or atopic dermatitis) requiring therapy; e.g., heart disease or cystic fibrosis which is judged by the investigator to have potential impact on study outcomes or safety.
- Severe or poorly controlled atopic dermatitis per investigator's discretion
- Past or current history of eosinophilic gastrointestinal disease
- Diagnosis of asthma that meets any of the following criteria:
- Uncontrolled asthma (as per Global Initiative for Asthma \[GINA\] latest guidelines)
- History of 2 or more systemic corticosteroid courses or 1 systemic course within the 3 previous months prior to visit 1 for treating wheezing
- Prior intubation/mechanical ventilation for asthma
- Currently receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy.
- Current participation in another clinical trial or participation in another clinical trial in the last 90 days
Key Trial Info
Start Date :
April 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03345160
Start Date
April 27 2018
End Date
October 7 2020
Last Update
October 29 2021
Active Locations (1)
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1
Johns Hopkins
Baltimore, Maryland, United States, 21287