drugset / Trial / NCT02949362

Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study

NCT02949362

Phase 3 Completed 29 enrolled Shire
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of teduglutide treatment of children with short bowel syndrome (SBS) who completed the TED-C13-003 study over a long-term period. It will evaluate how these children fared after the TED-C13-003 study ended. This study will also offer teduglutide treatment to eligible subjects, regardless of treatment received in TED-C13-003.

Timeline

Start
2016-12-09
Primary completion
2020-07-14
Completion
2020-07-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Teduglutide Peptide 0.05 mg/kg Subcutaneous

Indications