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Sponsored by: |
Ception Therapeutics |
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Information provided by: | Ception Therapeutics |
ClinicalTrials.gov Identifier: | NCT00635089 |
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-5-0002.
The goal of the study is to show longer term safety and efficacy in pediatric subjects who have eosinophilic esophagitis.
Condition | Intervention | Phase |
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Eosinophilic Esophagitis |
Drug: reslizumab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Safety and Efficacy Study of Reslizumab (CTx55700) for the Treatment of Pediatric Subjects With Eosinophilic Esophagitis Who Completed Study Res-5-0002 |
Estimated Enrollment: | 212 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Open-Label
Open-label active cohort
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Drug: reslizumab
initial dosing of reslizumab 1mg/kg i.v.monthly
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Subjects will enter this open-label extension study after completing the placebo-controlled, double-blind study Res-5-0002. The end of study visit for Res-5-0002 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.
Ages Eligible for Study: | 5 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | H Jeffrey Wilkins, MD | Ception Therapeutics |
Responsible Party: | Ception Therapeutics ( H. Jeffrey Wilkins, MD ) |
Study ID Numbers: | Res-5-0004 |
Study First Received: | March 6, 2008 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00635089 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Eosinophilic Esophagitis Cinquil |
Esophagitis Digestive System Diseases Esophageal Disorder Gastrointestinal Diseases |
Esophageal Diseases Gastroenteritis Eosinophilic Enteropathy |
Esophagitis Digestive System Diseases Gastrointestinal Diseases Esophageal Diseases Gastroenteritis |