Status:
COMPLETED
Salvage Peanut Oral Immunotherapy Study
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Peanut Allergy
Eligibility:
All Genders
1-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this trial is to study the safety of rescue peanut oral immunotherapy followed by the introduction of dietary peanut for patients with peanut allergy who have lost desensitization durin...
Detailed Description
Salvage Peanut Oral Immunotherapy Study is a single-arm, open label trial of peanut flour oral immunotherapy (OIT) administered for 6 months followed by introduction of dietary peanut for an additiona...
Eligibility Criteria
Inclusion
- Subjects who have completed an immunotherapy trial for peanut allergy within the last 6 months and are unable to tolerate ≥ 300mg of peanut.
- Age 1-65 years of either sex, any race, any ethnicity. Written informed consent from patient or parent/guardian (if \< 18 years) with participant's assent.
Exclusion
- Current participation in an interventional study for peanut allergy
- History of a severe anaphylactic reaction to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or SpO2 ≤ 92% at any stage, hypotension, confusion, collapse, loss of consciousness, or incontinence)
- Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease
- Severe asthma (2007 NHLBI Criteria Steps 5 or 6 , Appendix 2)
- Use of B blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
- Significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease) which would put the subject at risk for induction of severe food reactions.
- Pregnancy or lactation.
Key Trial Info
Start Date :
January 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03251508
Start Date
January 3 2018
End Date
November 23 2021
Last Update
January 30 2023
Active Locations (1)
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1
University of North Carolina
Chapel Hill, North Carolina, United States, 27514