FARE Clinical Trial Finder
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||7 Years - 55 Years|
- - 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
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Massachusetts General Hospital|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Wayne G Shreffler, MD, PhD|
|Principal Investigator Affiliation||Massachusetts General Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Active, not recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
The primary objective of the study is to identify and characterize a sub-population of peanut sensitized individuals who are not allergic to peanut and characterize their immunological phenotype in comparison with the low-threshold peanut allergic individuals enrolled in the adult PN OIT study (2012P002153/AADCRC MGH-004). The investigators also wish to identify and characterize the sub-population of high-threshold peanut-allergic individuals who have clinical reactivity to peanut allergen but only at higher doses and characterize their immunological phenotype in comparison with the low-threshold peanut allergic individuals enrolled in the adult PN OIT study (2012P002153/AADCRC MGH-004). Some of the The investigators will identify these high-threshold peanut allergic and sensitized, but non-allergic individuals by recruiting subjects who enrolled in 2012POO2153 but failed to meet all of the inclusion criteria
- - specifically, they failed to have objective symptoms during a food challenge with a cumulative total dose of 443 mg.
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
For additional contact information, you can also visit the trial on clinicaltrials.gov.