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NCT03345160 · ClinicalTrials.gov registry record · Phase 2

Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study

A Phase 2 study, sponsored by Johns Hopkins University.

Completed
Registry status
Phase 2
Development phase
7
Enrollment target

NCT03345160: Completed Phase 2 study, sponsored by Johns Hopkins University.

NCT03345160 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT03345160, a Phase 2 study, has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
Phase 2
Development phase
7 participants
Enrollment target

Study 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.

Primary Outcome

Number of participants who reported symptoms which were collected as AEs using CTCAE v4.0.

Interventions

  • DRUG Peanut Flour

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2018-04-27
Est. Completion 2020-10-07
Phase Phase 2
Johns Hopkins University

1,448 total trials

What the finished NCT03345160 record still lists

NCT03345160 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Peanut Flour is the first listed.

NCT03345160 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03345160 about?

NCT03345160 is a clinical study titled "Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study". 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 protoc...

What is the current status of trial NCT03345160?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2018-04-27. Estimated completion is 2020-10-07.

What interventions are being tested in trial NCT03345160?

The interventions under investigation include: Peanut Flour (DRUG).

Who is sponsoring clinical trial NCT03345160?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03345160's enrollment target sits among peer trials

7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03345160, the US trial registry maintained by the National Library of Medicine. NCT03345160 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.