Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis
Completed · Phase 3
Conditions studied: Eosinophilic Esophagitis
In brief
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.
Key facts
- Study ID
- NCT00635089
- Run by
- Ception Therapeutics
- People needed
- 190
- Starts
- 2008-07-01
- Expected to finish
- 2012-01-01
- Last updated by the study team
- 2017-03-23
Who can join
Age: 5 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Pregnant or nursing females
- Concurrent Immunodeficiency
- Current use of immunosuppressive drugs
- Did not tolerate study drug in Study Res-05-0002
Where it is running
- The Children's Hospital of Alabama — Birmingham, Alabama, United States
- University of Arizona Dept. of Pediatrics — Tucson, Arizona, United States
- Arkansas Children's Hospital/University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- Kaiser Permanente Hospital- Pediatric Gastroenterology — Hayward, California, United States
- Children'S Hospital of Orange County Pediatric Subspecialty Faculty Division of Allergy and Asthma — Orange, California, United States
- Pediatric Allergy/Immunology — Palo Alto, California, United States
- Children's Hospital of San Diego — San Diego, California, United States
- Denver Childrens At Aurora, Colorado — Aurora, Colorado, United States
- 1st Allergy and Clinical Research Center — Centennial, Colorado, United States
- Thomas Jefferson University Medical College — Wilmington, Delaware, United States
- Children's Center for Digestive Health Care — Atlanta, Georgia, United States
- University of Chicago — Chicago, Illinois, United States
- Children'S Memorial Hospital Division of Gastroenterology Hepatology & Nutrition — Chicago, Illinois, United States
- Riley Hospital for Children — Indianapolis, Indiana, United States
- Sinai Hospital of Baltimore — Baltimore, Maryland, United States
- Tuft's Floating Hospital — Boston, Massachusetts, United States
- Minnesota Gastroenterology — Plymouth, Minnesota, United States
- Saint Louis University — St Louis, Missouri, United States
- Creighton University Medical Center — Omaha, Nebraska, United States
- Las Vegas Pediatric Gastroenterology Associates — Las Vegas, Nevada, United States
- South Jersey Pediatric Gastroenterology — Mays Landing, New Jersey, United States
- Mount Sinai School of Medicine, Pediatrics — New York, New York, United States
- State University of New York (SUNY) — Syracuse, New York, United States
- Center for Digestive Allergic and Immunologic Diseases — Williamsville, New York, United States
- Pediatric Allergy and Immunology of Duke Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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