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Phase 2 N=640 Randomized Treatment

Promoting Tolerance to Peanut in High-Risk Children

Eczema · Egg Allergy · Food Allergy

Bottom Line

View on ClinicalTrials.gov: NCT00329784 ↗
Enrolled (actual)
640
Serious AEs
20.5%
Results posted
Dec 2016
Primary outcome: Primary: Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum — 36; 5; 18; 5 Participants — p=<0.0001

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Peanut Consumption Group (Biological)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion
May 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum		 36; 5; 18; 5 <0.0001 sig
PRIMARY
Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined		 54; 10 <0.0001 sig
SECONDARY
SCORAD at 60 Months		 7.6; 6.6 0.369
SECONDARY
Number of Participants With Asthma at 60 Months		 50; 54 0.642
SECONDARY
Number of Participants With Rhinitis at 60 Months		 106; 115; 134; 132 0.417
SECONDARY
Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm		 71; 30; 96; 102; 28; 25 <0.001 sig
SECONDARY
Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L		 93; 88; 120; 114; 99; 105 0.859

Summary

This study will evaluate whether early exposure to peanuts promotes tolerance and provides protection from developing peanut allergy in children who are allergic to eggs or who have severe eczema. This study has been continued into the ITN049AD (LEAP-On) Study (NCT01366846).

Eligibility Criteria

Inclusion Criteria

  • Able to consume solid food
  • Allergy to eggs and/or severe eczema
  • Informed consent obtained from parent or guardian.

Exclusion Criteria

  • Clinically significant chronic illness. Participants with eczema or recurrent wheeze are not excluded.
  • Positive skin prick test for peanut allergen with a wheel diameter greater than 4 mm in the presence of a negative saline control
  • Previous or current consumption of peanut protein that exceeds 0.2 g of peanut protein on at least one occasion or 0.5 g over a single week
  • Investigator-suspected allergy to peanut protein
  • Investigator-suspected allergy to peanut protein in care provider or current household member.
  • Diagnosis of persistent asthma
  • ALT (SGPT) or bilirubin greater than 2 times the upper limit of age-related normal value
  • BUN or creatinine greater than 1.25 times the upper limit of age-related normal value
  • Platelet count less than 100, 000/mL, hemoglobin less than 9 g/dL, or investigator-suspected immunocompromise
  • Unwillingness or inability to comply with study requirements and procedures
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00329784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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