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 |
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.
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
1 Children's Way
Little Rock, Arkansas 72202
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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13123 E 16th Ave
Aurora, Colorado 80045
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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