Status:
COMPLETED
Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis
Lead Sponsor:
Ception Therapeutics
Collaborating Sponsors:
Cephalon
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
5+ years
Phase:
PHASE3
Brief 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 o...
Detailed 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 scree...
Eligibility Criteria
Inclusion
- 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
- Pregnant or nursing females
- Concurrent Immunodeficiency
- Current use of immunosuppressive drugs
- Did not tolerate study drug in Study Res-05-0002
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00635089
Start Date
July 1 2008
End Date
January 1 2012
Last Update
March 23 2017
Active Locations (36)
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1
The Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
University of Arizona Dept. of Pediatrics
Tucson, Arizona, United States, 85724
3
Arkansas Children's Hospital/University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72202
4
Kaiser Permanente Hospital- Pediatric Gastroenterology
Hayward, California, United States, 94545