A Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects



Status:Recruiting
Conditions:Allergy, Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:12 - 50
Updated:1/24/2018
Start Date:November 24, 2017
End Date:February 28, 2018

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An Open-label Phase I Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects

The study aims to assess the biological potency of the In-House Reference Preparation (IHRP)
of peanut allergens extract by a quantitative Skin Prick Test (SPT) method in peanut-allergic
subjects.


Main Inclusion Criteria:

- Male or female subjects aged between 12-50 years

- Physician-diagnosed peanut allergy

- Subject currently following a strict peanut-free diet

- Documented history of positive test to peanut-specific IgE (ImmunoCAP system) >0.7
kU/L

- Positive peanut SPT with a largest wheal diameter ≥ 8 mm

Main Exclusion Criteria:

- Uncontrolled asthma

- Peanut allergen immunotherapy whatever the route, either ongoing or previously started
and having lasted more than one month (>30 days)

- Topical use of steroids within the past 14 days prior to the Screening SPT

- Inability to discontinue short-acting antihistamines

- Atopic dermatitis, eczema or urticaria on the areas to be tested
We found this trial at
2
sites
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Phone: 720-777-2575
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Aurora, CO
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Phone: 501-364-1060
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Little Rock, AR
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