CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 9 enrolled
Drug / intervention
Teduglutidedrug
Likely dose
Teduglutide 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/NCT03268811
NCT03268811Phase 3Completed
CompareCT.gov

A Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Japanese Pediatric Subjects With Short Bowel Syndrome Who Completed SHP633-302

Shire·interventional·Posted Aug 31, 2017·Updated May 24, 2022

In Brief

A Phase 3 clinical trial evaluating Teduglutide for Short Bowel Syndrome. Completed, enrolled 9 participants across 6 sites.

Detailed Summary

The purpose of this clinical study is to evaluate the long-term safety and tolerability of teduglutide treatment in Japanese pediatric participants with short bowel syndrome (SBS) who completed Study SHP633-302 (NCT02980666).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShort Bowel Syndrome
CountriesJapan
CollaboratorsTakeda

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 31, 2017
Enrollment StartAug 23, 2017
Primary CompletionNov 2, 2021
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 8.8 years ago

Interventions

Teduglutidedrug

Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.