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This multi-center study investigates the safety and therapeutic benefit of long-term treatment using the Viaskin Peanut 250 microgram drug patch to help children with peanut hypersensitivity. The use of a patch to deliver a peanut protein antigen to desensitize patients against allergic reactions is called epicutaneous immunotherapy, or EPIT. In the U.S., peanut hypersensitivity prevalence is growing, and among food allergies, peanut allergy is the most common cause of death.
This study is open to participants of both genders, who were previously enrolled in a 12-month precursor investigation (the PEPITES study), and it extends their participation for a total of 5 years on the patch.
Boys and girls: Ages 5 through 12 years at time of enrollment in the original PEPITES study
In this study extension, participants will use the Viaskin Peanut 250 microgram patch for up to 4 additional years if they used the Viaskin patch for 12-months in the PEPITES study, or for up to 5 years if they used a placebo patch. During this study extension, researchers will contact parents/guardians at specific intervals by telephone, and study visits will be required for physical exams and testing, including blood work, allergen skin tests, and pulmonary function tests. There are also provisions for participants to go off the patch at certain intervals to do a simple food challenge.
Visits: 15 to 21, dependent on whether participants received a placebo in the prior study
Duration: 53 to 64 months
Study Description at National Institutes of Health
Hey Jin Chong, MD, PhD
For more information about the study or enrollment, please contact:
Linette Milkovich, RN
Clinical Research Nurse Coordinator
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