CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 61 enrolled
Drug / intervention
TED +3 moredrug
Likely dose
TED 0.05 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02954458
NCT02954458Phase 3Completed
CompareCT.gov

A Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Patients With Short Bowel Syndrome Who Completed TED-C14-006 or SHP633-301

Shire·interventional·Posted Nov 3, 2016·Updated Mar 28, 2025

In Brief

A Phase 3 clinical trial evaluating TED, SOC, and 2 other interventions for Short Bowel Syndrome. Completed, enrolled 61 participants across 22 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShort Bowel Syndrome
CountriesBelgium, Canada, Finland, Italy, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 3, 2016
Enrollment StartJan 9, 2017
Primary CompletionNov 5, 2020
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 9.7 years ago

Interventions

TEDdrug

0.05 mg/kg SC injection once daily.

SOCother

Standard safety assessments and adjustments in nutritional support.

Syringedevice

Teduglutide will be administered using syringe.

Needledevice

Teduglutide will be administered using needle.