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Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study

NCT03345160 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-10-29

Study results available
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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.

Conditions

  • Treatment Efficacy

Interventions

DRUG

Peanut Flour

open label oral immunotherapy

Sponsors & Collaborators

Principal Investigators

  • Robert Wood, MD · Johns Hopkins School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-27
Primary Completion
2020-10-07
Completion
2020-10-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03345160 on ClinicalTrials.gov