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STEP-IT-UP - Peanut Allergy Study for Infants

NCT04761835 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-11-17

No results posted yet for this study

Summary

Multicenter randomized (1:1) trial of strict avoidance versus sub-threshold dietary introduction of peanut in peanut allergic infants 4-14 months of age who react at a minimum cumulative dose of at least 430 mg of peanut protein at initial oral food challenge (OFC) for 12 months, followed by cross-over to sub-threshold dietary introduction of peanut in those randomized initially to avoidance.

Conditions

Interventions

BIOLOGICAL

Peanut powder or peanut butter

Commercially available peanut powder or peanut butter.

Sponsors & Collaborators

Principal Investigators

  • Corinne Keet · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
4 Months
Max Age
14 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2026-11-01
Completion
2028-11-01
FDA Drug
Yes

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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 NCT04761835 on ClinicalTrials.gov