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Take Away Food Allergy; Inducing Tolerance in Children Allergic to Peanut

Study Purpose

The purpose of the study is to identify prognostic markers and possible success rate of tolerance induction to peanut allergens in children allergic to peanut.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 5 Years - 15 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Positive skin prick test or IgE to peanut - Age 5-15 yrs - Primary peanut allergy verified by objective symptoms to DBPCFC by a dose of 3 mg or more peanut potein

Exclusion Criteria:

- Non controlled asthma (by asthma control test, ACT) - Allergy/intolerance to any other ingredients in the vehicle used for the peanut DBPCFC - Current or previous allergen specific immunotherapy - Cardiac disease with increased risk of serious anaphylaxis - Severe atopic skin disease - Diabetes mellitus - Severe disease that interferes with adherence to study protocol

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02457416
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Oslo University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Geir Håland, MD PhD
Principal Investigator Affiliation Oslo University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries Norway
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Food Hypersensitivity
Additional Details

The study is an open randomized controlled study on oral immunotherapy including 60 children (40 on active treatment, 20 controls) with primary peanut allergy. The study has 4 phases: 1: inclusion/randomization including a double blind placebo controlled food Challenge 2: bi weekly up-dosing to maintenance dose after 48 weeks, 3: maintenance period of 3 years 4: 1 year follow up after end of treatment. Clinical parameters as well as immunological (serological and cellular) will be recorded at inclusion, after 3 months of up-dosing, at end of up-dosing, after 1 and 3 years of maintenance treatment and after 3 and 12 year of follow up.

Contact a Trial Team

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International Sites

Oslo, Norway

Status

Address

Oslo University Hospital, Department of Paediatrics

Oslo, , 0424

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