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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT02698033
Eligibility Criteria:
Inclusion Criteria:
* Failure to react to 443 mg of peanut protein during the DBPCFC1 visit of protocol 2012p002153 / AADCRC MGH-004.
* Males and females of all ethnic/racial groups aged 7-55 years old who are otherwise healthy.
* Willingness to sign consent (or for parent/guardian to sign consent).
* Willingness to sign the assent form, if consent provided by parent/guardian.
Exclusion Criteria:
* History of severe anaphylaxis
* Severe or Moderate asthma
* Poorly controlled asthma
* Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions or gastrointestinal inflammatory conditions
* Inability to cooperate with and/or perform oral food challenge procedures
* Primary Immune Deficiency
* Current use of beta blockers, angiotensin converting enzyme inhibitors, or monoamine oxidase inhibitors
* Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding
* Use within the past 6 months of other systemic immunomodulatory treatments
* Clinical signs or symptoms of anemia
* Hematocrit \<0.36 for adult females or \<0.38 for adult males
* Hematocrit \<0.34 for children 7-18 years of age
* Weight \<23 kg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
55 Years
Study:
NCT02698033
Study Brief:
Protocol Section:
NCT02698033