Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age



Status:Recruiting
Conditions:Allergy, Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:1 - 3
Updated:3/2/2019
Start Date:July 31, 2017
End Date:May 30, 2020

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Trial Summary
Trial Overview
Inclusion Criteria

A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.

The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization
to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by
EPicutaneous ImmunoTherapy (EPIT).


Key Inclusion Criteria:

- Male or female from 1-3 years of age;

- Physician-diagnosed peanut allergy;

- Peanut-specific IgE level > 0.7 kU/L;

- Positive peanut SPT with a largest wheal diameter ≥ 6 mm;

- Positive DBPCFC at ≤ 300 mg peanut protein;

Key Exclusion Criteria:

- Uncontrolled asthma;

- History of severe anaphylaxis to peanut;

- Prior immunotherapy to any food or other immunotherapy;

- Generalized severe dermatologic disease;
We found this trial at
27
sites
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas
Principal Investigator: Sara Anvari, MD
Phone: 832-825-4668
991
mi
from 43215
Houston, TX
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Emory University
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Brian VICKERY, MD
Phone: 404-727-8536
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
435
mi
from 43215
Atlanta, GA
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Cleveland Clinic
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Leigh Ann KERNS, MD
Phone: 216-444-6340
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
129
mi
from 43215
Cleveland, OH
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Mount Sinai Hospital
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Principal Investigator: Julie Wang, MD
Phone: 212-241-5548
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
480
mi
from 43215
New York, NY
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Children's Hospital of Philadelphia
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Terri Brown-Whitehorn, MD
Phone: 215-590-2549
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
416
mi
from 43215
Philadelphia, PA
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University of Rochester
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Jeanne Lomas, MD
Phone: 716-604-6928
University of Rochester The University of Rochester is one of the country's top-tier research universities....
354
mi
from 43215
Rochester, NY
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Stanford University School of Medicine
291 Campus Dr
Stanford, California 94305
(650) 725-3900
Principal Investigator: Sayantani Sindher, MD
Phone: 650-724-0293
Stanford University School of Medicine Vast in both its physical scale and its impact on...
2100
mi
from 43215
Stanford, CA
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University of Michigan Health System
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Principal Investigator: Georgiana M Sanders, MD
Phone: 734-936-5634
University of Michigan Health System The University of Michigan is home to one of the...
164
mi
from 43215
Ann Arbor, MI
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Children's Hospital Colorado
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: David M. Fleischer, MD
Phone: 720-777-2575
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
1153
mi
from 43215
Aurora, CO
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Dell Children's Medical center
Austin, Texas 78723
Principal Investigator: Pooja VARSHNEY, MD
Phone: 512-628-1870
1061
mi
from 43215
Austin, TX
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Johns Hopkins Hospital
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Robert Wood, MD
Phone: 410-955-5883
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
345
mi
from 43215
Baltimore, MD
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Boston Children's Hospital
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Lynda Schneider, MD
Phone: 617-355-6180
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
643
mi
from 43215
Boston, MA
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University of North Carolina Chapell Hill
Chapel Hill, North Carolina 27599
Principal Investigator: Edwin Kim, MD
Phone: 919-843-9087
354
mi
from 43215
Chapel Hill, NC
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Ann & Robert H. Lurie Children's Hospital of Chicago
225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Principal Investigator: Jacqueline Pongracic, MD
Phone: 312-227-6474
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
274
mi
from 43215
Chicago, IL
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The Universal of Chicago Medical Center
Chicago, Illinois 60637
Principal Investigator: Christina Ciaccio, MD
Phone: 773-834-4010
?
mi
from 43215
Chicago, IL
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Children's Medical Center of Dallas
1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Principal Investigator: Christopher Parrish, MD
Phone: 214-456-5730
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
911
mi
from 43215
Dallas, TX
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Riley Hospital for Children, Indiana University
Indianapolis, Indiana 46202
Principal Investigator: Kirsten KLOEPFER, MD
Phone: 317-278-7860
166
mi
from 43215
Indianapolis, IN
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Arkansas Children's Hospital
1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Principal Investigator: Stacie M. Jones, MD
Phone: 501-364-1060
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
622
mi
from 43215
Little Rock, AR
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University of California School of Medicine
Los Angeles, California 10833
Principal Investigator: Maria Garcia-Lloret, MD
Phone: 310-825-6481
?
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from 43215
Los Angeles, CA
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Le Bonheur Children's Hospital
Memphis, Tennessee 38103
Principal Investigator: Jay LIEBERMAN, MD
Phone: 901-287-7337
508
mi
from 43215
Memphis, TN
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Children's Hospital of Pittsburgh
3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Principal Investigator: Deborah Albright, MD
Phone: 412-692-8296
164
mi
from 43215
Pittsburgh, PA
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University of California, Rady Childrens Hospital
San Diego, California 92123
Principal Investigator: Stephanie Leonard, MD
Phone: 858-966-5961
?
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from 43215
San Diego, CA
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University of California at San Francisco
San Francisco, California 94143
Principal Investigator: Morna DORSEY, MD
Phone: 415-476-3086
2109
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from 43215
San Francisco, CA
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ASTHMA, Inc.
Seattle, Washington 98105
Principal Investigator: Daniel Petroni, MD
Phone: 206-525-5520
2005
mi
from 43215
Seattle, WA
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University of Arizona Health Science
Tucson, Arizona 85719
Principal Investigator: Heather Cassell, MD
Phone: 520-626-7780
?
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Tucson, AZ
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British Columbia Children's Hospital
Vancouver, British Columbia
Principal Investigator: Chan Edmond, MD
Phone: 1 604 875 2628
2046
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Vancouver,
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Children's National Health System
Washington, District of Columbia 20010
Principal Investigator: Hemant Sharma, MD
Phone: 202-476-6080
327
mi
from 43215
Washington,
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