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

Eosinophilic Esophagitis Clinical Trial

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

Clinical Trial 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-5-0002.

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

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00635089
Study type Interventional
Source Teva Pharmaceutical Industries
Contact
Status Completed
Phase Phase 3
Start date May 2008
Completion date January 2012
View Details
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