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Clinical Trials/NCT01259804
NCT01259804
Completed
Phase 1

Efficacy and Safety of High-dose Peanut Oral Immunotherapy With Factors Predicting Outcome

Cambridge University Hospitals NHS Foundation Trust1 site in 1 country22 target enrollmentStarted: January 2008Last updated:
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ConditionsPeanut Allergy

Overview

Phase
Phase 1
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
Pass/fail peanut challenge
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

Open pilot study of peanut oral immunotherapy in 22 children with peanut allergy

Detailed Description

Background Peanut allergy is severe and rarely resolves.

Objective To test the efficacy and safety of a new oral immunotherapy protocol for peanut allergy.

Method 22 peanut-allergic children will undergo oral challenge. Oral immunotherapy will be administered by gradual updosing with 2-weekly increments (8-38w) to 800mg protein (5 peanuts/day) followed by 30-weeks maintenance. Oral challenge will be repeated after 6 and 30 weeks maintenance.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
7 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Peanut allergy defined by oral challenge

Exclusion Criteria

  • •Major immunodeficiency

Outcomes

Primary Outcomes

Pass/fail peanut challenge

Time Frame: six months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Andrew Clark

Consultant

Cambridge University Hospitals NHS Foundation Trust

Study Sites (1)

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