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drugset / Trial / NCT01867671

Peanut Oral Immunotherapy in Children

NCT01867671 ↗

Phase 2 Completed 146 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network (ITN) · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in peanut-allergic children. Eligible participants with peanut allergy will be randomly assigned to receive either peanut OIT or placebo for 134 weeks followed by peanut avoidance for 26 weeks.

Timeline

Start
2013-08-13
Primary completion
2018-07-02
Completion
2018-12-21

Outcome

Met primary endpoint

registry analysis (superiority test); Peanut Oral Immune Therapy (OIT) vs Peanut Placebo; p <0.0001; Odds Ratio (OR) 205.45 (95% CI 24.00 to 1758.51); Regression, Logistic NCT01867671 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Peanut Oral Immunotherapy - Liquid Extract Unknown 0.8 mg Oral
Subject Peanut Oral Immunotherapy - Peanut Flour Unknown 12 mg Oral

Indications

No indication recorded.