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PostPosted: Sat Aug 13, 2016 9:00 am 
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Joined: Thu Dec 20, 2007 7:23 pm
Posts: 1099
Location: Kingston
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) (PALISADE)

Quote:
Detailed Description:
This is an international, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of AR101 in a characterized desensitization oral immunotherapy regimen in peanut-allergic individuals.


Quote:
Eligibility

Ages Eligible for Study: 4 Years to 55 Years (Child, Adult)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Key Inclusion Criteria:

Age 4 through 55 years
Clinical history of allergy to peanuts or peanut-containing foods
Serum immunoglobulin E (IgE) to peanut ≥0.35 kUA/L (kilos of allergen-specific units per liter, determined by UniCAP™* within the past 12 months) and/or a skin prick test (SPT) to peanut ≥3 mm compared to control
Experience dose-limiting symptoms at or before the 100 mg challenge dose of peanut protein (measured as 200 mg of peanut flour) on Screening DBPCFC conducted in accordance with PRACTALL** guidelines
Not be residing at the same address as another subject in this or any peanut OIT study


https://clinicaltrials.gov/ct2/show/stu ... 1#contacts

_________________
Mary


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