Sponsor study identifier
Secondary identifiers
observational
20
0 countries
N/A
Study Start
December 9, 2015
Actual (reported)Primary Completion
July 7, 2016
Actual (reported)Study Completion
August 22, 2019
Actual (reported)This protocol is designed to better characterize a sub-population of peanut sensitized individuals who may be non-allergic, despite significant sensitization, or who may be allergic, but at high threshold doses. By specifically targeting participants who met the initial screening criteria of the active adult PN OIT study, Protocol 2012p002153 / AADCRC MGH-004 (MGH-004), but failed to react during the pre-treatment 443 mg challenge to peanut, the investigators anticipate that the investigators will identify individuals who have become spontaneously tolerant, despite persistent sensitization. The investigators might also find that clinical sensitivity persists but only with higher thresholds, or that sensitivity has increased (or is variable) since the previous allergen exposure. By repeating DBPCFCs through to a full serving dose (7.4 gram), the investigators will distinguish participants who react only at higher doses from those who were not truly peanut allergic, address whether their sensitivity has changed, and have the opportunity to further investigate their immune response to peanut allergen.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 22, 2019
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 9, 2015
Actual (reported)January 29, 2016
Actual (reported)March 3, 2016
Actual (reported)July 7, 2016
Actual (reported)August 22, 2019
Actual (reported)October 3, 2019
Actual (reported)Consistency of High Threshold Reactivity
The proportion of high-threshold peanut allergic individuals among participants who previously failed to react to a 443 mg peanut protein challenge in NCT01750879 who also reacted \>443 cumulative total dose on repeat challenge
4 weeks
Individuals who tolerated without dose limiting symptoms the screening food challenge for a parent interventional trial
A Double-blind, placebo-controlled food challenge will consist of two challenges performed on separate days. One challenge will consist of 7 doses of peanut given every 20 minutes in increasing amounts up to a total of 7 grams of whole peanut (4 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
A Double-blind, placebo-controlled food challenge will consist of two challenges performed on separate days. One challenge will consist of 7 doses of peanut given every 20 minutes in increasing amounts up to a total of 7 grams of whole peanut (4 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
A sub-population of peanut sensitized individuals who may be non-allergic, despite significant sensitization, or who may be allergic, but at high threshold doses.
PBMC
Wayne G Shreffler, MD, PhD
Massachusetts General Hospital
20 participants (actual enrollment reported by the registry).
First Submitted
January 29, 2016
First Posted
March 3, 2016
Study Start
December 9, 2015
Actual (reported)Clinical and Biological Efficacy of Peanut Oral Immunotherapy
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Primary Completion
July 7, 2016
Actual (reported)Study Completion
August 22, 2019
Actual (reported)Last Updated
October 3, 2019
Results First Posted
October 3, 2019
Record last verified: 2019-10
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Source: ClinicalTrials.gov.
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