drugset / Trial / NCT02954458

Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)

NCT02954458

Phase 3 Completed 61 enrolled Shire
NaSingle-groupOpen-labelTreatment

Summary

This study will follow participants who completed the TED-C14-006 study. The purpose of this study is to evaluate the long-term safety and efficacy of teduglutide in pediatric participants with Short Bowel Syndrome (SBS). This study will also offer teduglutide treatment to eligible participants, regardless of treatment received in TED-C14-006 or SHP633-301.

Timeline

Start
2017-01-09
Primary completion
2020-11-05
Completion
2020-11-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Teduglutide Peptide 0.05 mg/kg Subcutaneous

Indications