Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using (CPNA) Peanut OIT Safety Follow-On Study



Status:Completed
Conditions:Allergy, Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:4 - 26
Updated:2/17/2019
Start Date:August 2014
End Date:April 11, 2018

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Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) Safety Follow-On Study

This is a multi-center, open-label, follow-on study to gather additional information on the
safety and tolerability of oral desensitization with CPNA in the subjects who participated in
ARC001.

All subjects will receive daily oral dosing of peanut OIT (oral immunotherapy) in the form of
Characterized Peanut Allergen (CPNA).

Study Duration - 12-90 weeks before reaching the Extended Maintenance Phase. All Subjects may
continue Extended Maintenance Phase until CPNA becomes commercially available or the study is
terminated.

Inclusion Criteria:

- Completion of ARC001 study

- Use of birth control for females of child-bearing age

- No change in the status of any longitudinally applicable ARC001 inclusion criteria

Exclusion Criteria:

- Early termination from ARC001

- Failure to tolerate 300 mg of peanut protein in the ARC001 exit food challenge

- A lapse in dosing of more than 10 days from completion of ARC001

- Change in the status of any longitudinally applicable ARC001 exclusion criteria
We found this trial at
8
sites
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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Cincinnati, OH
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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Dallas, TX
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
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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San Diego, California 92093
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San Diego, CA
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