CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 29 enrolled
Drug / intervention
Teduglutide +1 moredrug
Likely dose
Teduglutide 0.05mg/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/NCT02949362
NCT02949362Phase 3Completed
CompareCT.gov

A Retrospective and Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed TED-C13-003

Shire·interventional·Posted Oct 31, 2016·Updated Mar 19, 2025

In Brief

A Phase 3 clinical trial evaluating Teduglutide and SOC for Short Bowel Syndrome. Completed, enrolled 29 participants across 11 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShort Bowel Syndrome
CountriesUnited Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 31, 2016
Enrollment StartDec 9, 2016
Primary CompletionJul 14, 2020
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 9.7 years ago

Interventions

Teduglutidedrug

0.05mg/kg

SOCother

Standard safety assessments and adjustments in nutritional support will be provided for all subjects throughout the study, including any teduglutide treatment periods