Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||1 Year - 65 Years|
- - 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of North Carolina, Chapel Hill|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Edwin Kim, MD|
|Principal Investigator Affiliation||University of North Carolina, Chapel Hill|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Enrolling by invitation|
The disease, disorder, syndrome, illness, or injury that is being studied.
Salvage Peanut Oral Immunotherapy Study is a single-arm, open label trial of peanut flour with 6 month active treatment and 6 month follow-up on peanut food equivalent. The first stage with 6 months treatment will involve approximately 3 months of build up phase (desensitization) to a certain maintenance dose ( 300 mg peanut protein) then 3 months of maintenance phase where subjects take daily 300 mg of peanut protein. After that the subjects will start a food equivalent that contains 300 mg of peanut protein only. During both phases subjects will be monitored for adverse events including gastrointestinal side effects. They will also be monitored for any anaphylaxis or Epipen use. Data regarding compliance with the drug will be collected as well.
Experimental: Peanut OIT/food equivalent
Single arm study with all subjects receiving peanut OIT study drug for the initial 6 months followed by an equivalent amount of peanut food for an additional 6 months.
Drug: - Peanut OIT
Participants will be given increasing doses of the peanut oral immunotherapy (OIT) study drug every 2 weeks for 3 months up to the 300 mg maintenance dose and will maintain this dose for 3 months. Subjects will then switch to a food equivalent that contains 300 mg of peanut protein for an additional 6 months.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
University of North Carolina
Chapel Hill, North Carolina, 27514