Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis

Last updated: February 2, 2017
Sponsor: Ception Therapeutics
Overall Status: Completed

Phase

3

Condition

Esophageal Disorders

Heartburn

Heartburn (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00635089
Res-5-0004
  • Ages > 5
  • All Genders

Study Summary

This study is an open-label study where all subjects will receive active drug, reslizumab. Subjects are able to enter this trial only through completion of study Res-05-0002 (NCT00538434).

The goal of the study is to show longer term safety and efficacy in pediatric subjects who have eosinophilic esophagitis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed consent

  • Received at least two doses of study drug in Study Res-05-0002 (NCT00538434)

  • Did not withdraw from Study Res-05-0002 due to drug related adverse event

  • Completed End of Treatment Visit for Study Res-05-0002

Exclusion

Exclusion Criteria:

  • Pregnant or nursing females

  • Concurrent Immunodeficiency

  • Current use of immunosuppressive drugs

  • Did not tolerate study drug in Study Res-05-0002

Study Design

Total Participants: 190
Study Start date:
July 01, 2008
Estimated Completion Date:
January 31, 2012

Study Description

Subjects will enter this open-label extension study after completing the placebo-controlled, double-blind study Res-5-0002 (NCT00538434). The end of study visit for Res-05-0002 will serve as the screening visit for this trial.

All subjects will receive reslizumab and be followed by their principal investigators in an unblinded fashion. Visits and administration of reslizumab will be monthly.

Connect with a study center

  • Pediatric Allergy and Immunology

    Edmonton, Alberta T6G 2C8
    Canada

    Site Not Available

  • University of Montreal

    Montreal, Quebec H3T 1C5
    Canada

    Site Not Available

  • The Children's Hospital of Alabama

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of Arizona Dept. of Pediatrics

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Arkansas Children's Hospital/University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Kaiser Permanente Hospital- Pediatric Gastroenterology

    Hayward, California 94545
    United States

    Site Not Available

  • Children'S Hospital of Orange County Pediatric Subspecialty Faculty Division of Allergy and Asthma

    Orange, California 92868
    United States

    Site Not Available

  • Pediatric Allergy/Immunology

    Palo Alto, California 94305
    United States

    Site Not Available

  • Children's Hospital of San Diego

    San Diego, California 92123
    United States

    Site Not Available

  • Denver Childrens At Aurora, Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • 1st Allergy and Clinical Research Center

    Centennial, Colorado 80112
    United States

    Site Not Available

  • Thomas Jefferson University Medical College

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • Children's Center for Digestive Health Care

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Children'S Memorial Hospital Division of Gastroenterology Hepatology & Nutrition

    Chicago, Illinois 66014
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Riley Hospital for Children

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Sinai Hospital of Baltimore

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • Tuft's Floating Hospital

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Minnesota Gastroenterology

    Plymouth, Minnesota 55446
    United States

    Site Not Available

  • Saint Louis University

    St. Louis, Missouri 63104
    United States

    Site Not Available

  • Creighton University Medical Center

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • Las Vegas Pediatric Gastroenterology Associates

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • South Jersey Pediatric Gastroenterology

    Mays Landing, New Jersey 08330
    United States

    Site Not Available

  • Mount Sinai School of Medicine, Pediatrics

    New York, New York 10029
    United States

    Site Not Available

  • State University of New York (SUNY)

    Syracuse, New York 13210
    United States

    Site Not Available

  • Center for Digestive Allergic and Immunologic Diseases

    Williamsville, New York 14221
    United States

    Site Not Available

  • Pediatric Allergy and Immunology of Duke Medical Center

    Durham, North Carolina 27720
    United States

    Site Not Available

  • Cincinnati Children's

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Greenville Health System

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • University of Texas Southwest Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • University of Utah School of Medicine

    Salt Lake City, Utah 84113
    United States

    Site Not Available

  • Children's Pavilion

    Richmond, Virginia 23298-0264
    United States

    Site Not Available

  • Carilion Medical Center for Children

    Roanoke, Virginia 24013
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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