Salvage Peanut Oral Immunotherapy Study

• Status: Enrolling by invitation
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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 during a peanut immunotherapy trial.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.