CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 11 enrolled
Drug / intervention
Teduglutide +3 moredrug
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/NCT03596164
NCT03596164Phase 3Completed
CompareCT.gov

An Open-Label, Extension Study of Teduglutide in Japanese Subjects With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004

Takeda·interventional·Posted Jul 23, 2018·Updated Mar 15, 2023

In Brief

A Phase 3 clinical trial evaluating Teduglutide, Syringe, and 2 other interventions for Short Bowel Syndrome. Completed, enrolled 11 participants across 5 sites.

Detailed Summary

The purpose of this clinical study is to evaluate the long-term safety and efficacy of teduglutide in Japanese participants with PN/IV (parenteral nutrition/intravenous)-dependent SBS (short bowel syndrome) who completed SHP633-306 or who were in the extension phase of the TED-C14-004 (NCT02340819) study.

Study Details

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

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJul 23, 2018
Enrollment StartJul 9, 2018
Primary CompletionJan 13, 2022
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 7.9 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.

Syringedevice

Teduglutide will be administered using syringe. Syringe is approved for use in Japan by PMDA.

Needledevice

Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.

Vial Adapter for Devicedevice

Vial adapter for device is approved for use in Japan by PMDA.