Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT03345160
Eligibility Criteria:
Inclusion Criteria:
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 Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
9 Years
Study:
NCT03345160
Study Brief:
Protocol Section:
NCT03345160