CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 7 enrolled
Drug / intervention
Peanut Flourdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03345160
NCT03345160Phase 2Completed
CompareCT.gov

Open Label Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study

Johns Hopkins University·interventional·Posted Nov 17, 2017·Updated Oct 29, 2021

In Brief

A Phase 2 clinical trial evaluating Peanut Flour for Treatment Efficacy. Completed, enrolled 7 participants across 1 site.

Detailed Summary

This application is being submitted as a follow-up to Protocol "Oral Immunotherapy for Induction of Tolerance in Peanut Allergic Children-The IMPACT Study." The IMPACT study was a double-blind, placebo-controlled study of peanut oral immunotherapy in children 12-48 months of age. As part this protocol, all participants who received placebo treatment were promised the opportunity to receive open label treatment at the conclusion of the double-blind phase and initial follow-up. At the time of submitting that protocol, the investigator did not specify any detailed protocol for the open label crossover treatment, as this is an evolving field, but the investigator is now ready to offer this open label treatment as promised.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTreatment Efficacy
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 17, 2017
Enrollment StartApr 27, 2018
Primary CompletionOct 7, 2020
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 8.6 years ago

Interventions

Peanut Flourdrug

open label oral immunotherapy