FARE Clinical Trial Finder

Simplify your search for a clinical trial and help researchers discover new therapies. The FARE Clinical Trial Finder links patients with food allergy and healthy, non-patient volunteers to actively recruiting food allergy studies.

Salvage Peanut Oral Immunotherapy Study

Study Purpose

The purpose of this trial is to provide salvage peanut oral immunotherapy for patients with peanut allergy.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.

Interventional
Eligible Ages 1 Year - 65 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

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.

NCT03251508
Phase

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
Lead Sponsor

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
Principal Investigator

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
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Peanut Allergy
Additional Details

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.

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

Status

Address

University of North Carolina

Chapel Hill, North Carolina, 27514

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.